Roles and Responsibilities Responsible for screening volunteers for clinical study and to decide the eligibility of a subject based on detailed history, physical examination, radiological and electrocardiograph and laboratory parameters. Monitoring, Reporting and Management of Adverse Events/ Serious Adverse Events occurring during clinical study Determination of Volunteer eligibility for Clinical Study as per Inclusion/exclusion criteria of protocol. Maintenance of Emergency Drugs List and ICU set-up. Maintain records of screening procedures as per GCP and other applicable regulatory requirements. Co-ordinate with respective CI/PI/Head in all study related activities. Perform any other activities as and when assigned by the management Desired Candidate Profile Qualification: MBBS with Medical Council registration Job Location: Mangalore - Karnataka (Office based)
Role & responsibilities Development and validation of bioanalytical methods using LCMS and other sophisticated instruments. Routine calibration of the instruments. Strong basic knowledge about Analytical instruments of LCMS, HPLC, HPTLC, GC-MS and other instruments. Good understanding of GLP and documents thereof. Knowledge of USFDA guidelines. Excellent communication skills & co-ordination among all the team members. Should possess good interpersonal and management skills Accountable for the whole group productivity in terms of number of samples, analysis, quality, quantity timelines better Turn Around Time (TAT) improvement Preferred candidate profile The candidate should have 1-3 years of experience in Bioanalytical Lab.
About Navitas Life Sciences: Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries. At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider. Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry. Navitas Life Sciences is proud to be an HIG Portfolio company. Key Skills : PV, End to End Case processing, Understanding of regulation guidelines Education: MPharm and BPharm Responsibilities & functions: Individual Case Safety Report Responsible for Data entry services Responsible for data entry of individual case safety reports (all case report types) into the safety database. Review and evaluate AE case information to determine required action based on and following internal policies and procedures. Process all cases to meet timelines as per prioritisation with defined quality and productivity in order to meet the project SLAs/KPIs. Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD) Responsible for writing and /or checking for correctness and completeness of the medically relevant safety narrative in chronological order. Responsible for checking the completeness and accuracy of the data entered in the various fields. Perform self-quality check before routing the case to the next workflow. Source document preparation and archival will be done as required. Performing necessary changes in the demoted/back routed cases from Quality reviewer/ Medical reviewer. Addressing case corrections for any internal/external findings post case locking. Generate follow up queries where necessary. Maintain Knowledge of global health authority regulations and requirements Support the team with other additional tasks as needed. Reviewing the QR feedback received and if necessary, ensure that the feedback comments were addressed. Co-ordinate with other workflows as required. Support leads/manager on operational activities as needed.
About Navitas Life Sciences: Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries. At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider. Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry. Navitas Life Sciences is proud to be an HIG Portfolio company. Website: www.navitaslifesciences.com Responsibilities & functions: MICC Efficiently manage MICC service lines Have complete oversight on assigned MICC projects Apply knowledge & expertise for project progress Coordinate with projects Leads & external stakeholders Active involvement in Business Development and new Proposals All the following responsibilities and functions are undertaken in line with Navitas Life Sciences (NLS) current Standard Operating Procedures (SOPs), Policies and ICH-GCP. The duties and responsibilities listed below are representative of the nature and level of work assigned and are not necessarily all-inclusive: Manage MICC services for Clients across the Globe Ensure adequate levels of available capacity & capabilities for MICC services. Build and improvise MICC process and develop. Manage Delivery, resource utilization, and People management. Manage resources in such a way that agreed delivery performance (cost, compliance, quality, SLA, KPIs/CTS, employee satisfaction, trend analysis) can be maintained at all the times. Participate in Workflow, Operational/any client specific or other stakeholder meetings. Review Deviations & CAPA for respective errors and ensure preventive measure are in place. • Provide project specific performance feedback to the management and escalate issues in a timely manner. Provide all delivery related risks, issues, and client specific issues/escalations to the management team. Provides oversight and guidance on organizational goals and company objectives Monitoring the quality of work and efficiency of team members with contracted scope of work and Safety Management Plan & MICC Data Entry Specification. Participate/Support in Audits and responsible for closing CAPAs on time. Manage other workflows as needed MICC subject matter expert- Experience in Medical Information Contact Centre (MICC) to support services for Clients across the Globe Other Responsibilities Read and acknowledge all necessary NLS and Sponsors standard operating procedures as required. Participation in local or global project teams, including on-time delivery of assigned responsibilities. Collaborate in the development, review, and initiation of SOPs. Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects. Support oversight on operational activities and sound understanding on project plans/documents. Participate in team meetings and provide regular feedback to the management on operational metrics and other challenges/issues. Participate in trainings offered by NLS and sponsors and contribute to identification and implementation of process efficiencies. Liaise with managers and in proactively identifying issues and proposing solutions. Providing technical reports, metrics, invoices, and support on new initiatives Delegating client requests and ensure it is addressed within the timelines. Perform MICC agent activities, if needed Always exhibits a detail-oriented etiquette and friendly attitude when answering telephone calls.
Role & responsibilities Performing as Sub-investigator in the assigned clinical studies Reviewing study documents Preparation of Clinical Raw data Protocol, SOP and various Regulatory compliance Protocol/ICF/CSR review Study initiation and Execution Pre study document preparation Dosing of the subjects Monitoring the study process Preparation of confinement report, clinical updates & clinical summary report Compilation of study documents as per protocol Review study documents and handing over to QA for review. Close the QA / Sponsors observation / queries Archival & Retrieval of study documents Subject safety follow-up Serving as QC in the assigned clinical studies Performing pharmacy activities. EC submission of protocols and related activities Preferred candidate profile Knowledge of ICH - GCP Knowledge in Regulatory guidelines like CDSCO, USFDA, EMEA, WHO etc., Communication skills
Job Responsibilities: Checking vital sign as per SOP and protocol and filling in the vital CRF Reporting and assisting in the management of any adverse event Maintaining and updating stock of the emergency medicines and filling up of the Relevant forms IV Cannulations and Collection of blood samples during study and screening Filling the respective log book meant for emergency medicines Labelling of vacutainers, Checking the labels of vacutainers and cryo vials Management of BA/BE and ICU wards Maintenance of ICU ward instruments and the respective log books Ensuring the relevant study procedures are carried out in compliance with SOP and protocol Ensuring disposal of bio waste as mentioned in the SOP Recording the temperature and humidity of the Ward, sample collection and ICU Ensuring availability of adequate stock materials required for phlebotomy and medical related activities in upcoming studies Volunteer registration and checking BMI during screening of volunteers Investigation product administration Updating contract staff training files. Screening & registration activities. Compilation of screening reports and study reports, entering lab values. Segregation of the samples. Desired Candidate Profile: 0-5 years of experience in Nursing(ANM/GNM/B.Sc Nursing) Should have valid 'Nursing Council' registration certificate.
Job Description We are currently seeking a Study Nurse to join our growing team. The role will include the following: Checking vital signs as per SOP and protocol and filling in the vital CRF Reporting and assisting in the management of any adverse event(s) Maintaining and updating stock of emergency medicines and filling up of the relevant forms IV cannulations and collection of blood samples during study and screening Filling the respective logbook meant for emergency medicines Labeling of vacutainers, Checking the labels of vacutainers and cryo vials Management of BA/BE and ICU wards Maintenance of ICU ward instruments and the respective logbooks Ensuring the relevant study procedures are carried out in compliance with SOP and protocol Ensuring disposal of bio waste as mentioned in the SOP Recording the temperature and humidity of the Ward, sample collection and ICU Ensuring availability of adequate stock materials required for phlebotomy and medical related activities in upcoming studies Volunteer registration and checking BMI during screening of volunteers Investigation product administration Updating contract staff training files. Screening and registration activities. Compilation of screening reports and study reports, entering lab values. Segregation of the samples. Desirable Skills and Experience 0 2 years experience with Nursing Council registration Good communicator Computer literate Manipal, India ANM/GNM/BSc Nursing Entry Level Clinical Research
About Navitas Life Sciences: Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries. At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider. Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry. Navitas Life Sciences is proud to be an HIG Portfolio company. Website: www.navitaslifesciences.com Responsibilities and functions: Independently and accurately, review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures. Independently and accurately, perform Medical Coding with MEDRA and WHODRUG Global for completeness, accuracy and consistency in accordance with all applicable procedures. Accurately and consistently, apply data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures. Perform Quality Reviews and appropriately address all issues. Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures. Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings. Independently and accurately, generate data queries to resolve data discrepancies. Appropriately address responses to data queries and accurately update the clinical data as necessary. Identify and accurately resolve all workflow or clinical data discrepant issues. Independently and accurately, prepare database test documentation and test data entry screens. Assist with the validation of edit check programs. Assist with the development, review and the update of relevant Data Management Study Specific Procedures. Accurately perform Serious Adverse Event reconciliation in accordance with all applicable procedures. Accurately perform external data reconciliation in accordance with all applicable procedures. Generate, review for accuracy and distribute status reports as requested.
Telugu Clients Make outbound calls to PG owners in Bengaluru Explain our offer for PG promotions Convince and follow up with clients using CRM/Google Sheet Share WhatsApp links, flyers, videos Maintain a basic log of calls, leads, and conversions Sales incentives Performance bonus
Responsibilities and functions: Handling full cycle of Recruitment from sourcing of candidates through in-house database, using portals, referrals. Actively contribute to recruitment by preparing job descriptions, posting ads, and managing the entire hiring process. Use social media, job boards, Internet sourcing, and other technical means to source candidates for open jobs. Short- listing and aligning candidates for interviews based on job requirements. Create assessment and interview schedules and seamlessly manage coordination, Scheduling & coordinating interviews. Sift applications received to identify the most suitable applicants for jobs. Responsible for Sourcing, Delivery, TAT, SLA, HR Operation Conducts pre-employment screening. Carry out all administrative arrangements for those attending a selection process, including arranging tests and providing suitable arrangements for applicants with special needs. Must facilitate the background verification process with 100% compliance. Must facilitate the on-boarding process with 100% compliance. Prepare all documentation relating to appointments including offer lette
Roles & Responsibilities: Must facilitate the on-boarding process with 100% compliance Adherence to Global SOP Evaluating the effectiveness of Learning programs and making improvements as needed. Support with assessing and coordinating improvements of TRMS. Initiate trainings on time based on requirements 100% of compliance in Maintenance of Learning records. Support and follow up on audit related closures on time Conduct training programs as per plan. Participate in Audits and submit all evidence on time. Audit Reports, no.of NCs Timely response to RFP's and attend the client / internal / external with appropriate artifacts Must facilitate the Learning process with 100% compliance.
About Navitas Life Sciences: Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries. At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider. Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry. Navitas Life Sciences is proud to be an HIG Portfolio company. Website: www.navitaslifesciences.com Expereince : 1-3 Years Skill Set: Signal and Aggregate expereince Responsibilities & functions: Medical Reviewer Aggregate Reports and Risk Management Plans Responsible for the implementation of operational tasks in the field of safety writing Overseeing the service performance Mentoring employees enabling them to work independently within timelines, budget, and quality Review the RMP/PSUR or any aggregate documents for medical cohesiveness Managing all logistical aspects related to the timely development of the safety reports, work with authors of the different line functions to ensure the content meets client and Health Authorities requirements/expectations Develops and dispatches project specific slides for both internal and external parties Participate in internal and external audits and inspections by clients and health authorities. Ensure that all trackers related to NLS and client specific procedures are in place and updated on timely basis. Ensures the project team members in completion of all NLS or client specific trainings. Conducts trainings as required for improvement of team performance As required, authors and reviews RMPs, DSURs, PBRERs, PSURs, PADERs and Canadian Aggregate Reports Provides expertise required for the finalization of the RMPs, DSURs, PBRERs, PSURs, PADERs and Canadian Aggregate Reports and its annexes. Resolve issues as they arise. Ensure proper maintenance of all RMPs, DSUR’s, PBRER’s, PSUR’s, PADER’s and Canadian Aggregate Reports Supports in drafting and implementation of NLS or client specific SOPs or WIs. Provides inputs in client specific guidance documents. Acts as Point of contact for NLS aggregate team and client. Signal Management and Risk Management Plans Screening, data mining and frequency tabulation for potential signals including signal estimation using appropriate signal detection tool as per the client requirement. Generation of line listings and summary tabulations from Argus/client safety database. Drafting Signal detection, validation, assessment and benefit-risk analysis and prioritisation of signals by reviewing available data. Ensure compliance to appropriate signal SOPs, conventions and guidelines for all activities performed. Tracking of identified signals from regulatory and internal signal detection process and monitoring the status of signals: potential signals, open signals, refuted signals and validated signals. Developing Risk Management Plans and associated activities as per NLS/client specific SOPs Other Responsibilities Assist or support Individual Case Safety Report team as per the workload in respective teams Assist or support Literature review team as per the workload in respective teams Assisting in scheduling of reports assigned to the team Assis Manager/designee in allocation, tracking of reports developed by the team Conduct daily status meetings as required for the projects Support in creating/ updating SOPs as required Ensure team compliance in delivering the reports Qualifications & competences: Graduate or post graduate degree in life sciences, pharmacy, medicine, dentistry, allied health sciences and any additional related courses. Good understanding of medical and Pharmacovigilance terminologies Good knowledge of GCP, GVP, ICH, USFDA guidelines and any other pharmacovigilance related guidelines and regulations Basic competence with medical and therapeutic terminology. Understanding of patient safety regulatory obligations. Should be familiar with regulatory and pharmacovigilance guidelines. Good command of written and spoken English; additional languages favourable Good knowledge of usual office software (MS Office: Word, Excel, Power point) Soft skills (motivation, strong communication competence, structured in work, organising skills, reliability commitment and capacity for teamwork).
Role & responsibilities Responsible for preparation of PK and Statistical Analysis and Statistical reports (BA/BE and Phase 1) for various regulatory submissions. Provide statistical input and sample size calculations during protocol design Provide statistical/programming inputs for CRF design and review Generate randomization lists Prepare statistical analysis plans Perform blinded statistical review to check for data discrepancies Generate statistical analysis data sets Develop programming requirements documents for SAS programmers Perform data analysis and prepare statistical reports Generate data listings, tables and graphs Develop programs for quality control of analysis programs Provide Stat training to SAS programmers and knowledge sharing to statisticians Prepare integrated summaries of efficacy & safety and answer regulatory queries Understand and comply with all SOPs Preparation of appendices in eCTD format. Responsible to respond the sponsor/ regulatory queries Preferred candidate profile The candidate should have minimum 5+yrs experience in BA/BE and Phase-1 studies.
Role & responsibilities End-to-end project coordination for the assigned clients with effective client interface, communication, and time delivery of the projects. Ensuring work in compliance to SOPs, processes, and requirement of Management. Feasibility, proposal development, follow-up, and finalizing of the project contract for the BE projects for the assigned clients. Coordinate & facilitate sponsor visits during in-process and retrospective study monitoring. Act as a management designee in double-blinded studies if assigned. Coordination among internal team to ensure timely delivery of projects. Publishing a project schedule to the team with appropriate tracking of milestones. Facilitate inventory management of biological samples, investigational products, and documents to have proper track. Managing the CSR schedules and dispatch call. Managing and coordinating the clinical data entry team with the CDS team for CDISC datasets. Contributing to overall project objectives. Interpersonal relationship with the study team. Communicating the projects goals throughout the organization. BCSO calls for BA/BE centre capacity utilization. Coordinating IEC and IP/Plasma sample storage calls. Preferred candidate profile The candidate should have minimum 7+ years of experience in BA/BE Project management. Good in written and verbal communication. Good in presentation skills
About Navitas Life Sciences: Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries. At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider. Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry. Navitas Life Sciences is proud to be an HIG Portfolio company. Website: www.navitaslifesciences.com Responsibilities & functions: ICSR Clinical Trial To assist in lead activities in clinical or post-marketing pharmacovigilance service lines. Apply knowledge & expertise for decision making activities on process related activities. Provide oversight on assigned operational projects and act as a mentor in the team. All the following responsibilities and functions are undertaken in line with Navitas Life Sciences (NLS) current Standard Operating Procedures (SOPs), Policies and ICH-GCP. The duties and responsibilities listed below are representative of the nature and level of work assigned and are not necessarily all-inclusive: Workflow Planning: Assign project level lead/Manager (WL/WM) to manage delivery across all workflows including, daily workflow monitoring like intake of reports, workflow allocation and tracking, prioritization, submissions, Compile EOD reports, Query followups, Reconciliations. Schedule and lead workflow meetings with Delivery Leads/Project Managers. Workflow reports/dashboard - Publish daily/weekly/monthly status report for projects Monitor KPIs/CTS//SLA at project level. Drive continuous improvements including automation. Submissions Manage Workflow Management & Submissions Ensure adequate levels of available capacity & capabilities for Workflow manager/Lead for management of Submissions Manage Delivery, resource utilization, people management Effectively manage Submission workflow in such a way that agreed delivery performance (cost, compliance, quality as per Client/Project requirements) can be maintained at all times Responsible for submission/distribution of reports for both expedited cases (SUSAR) and periodic reports to regulatory authorities, partners, sites/investigators/IRBs (if applicable) Planning and monitoring cases/reports requiring submissions Ensure compliance to SLA/Client/Regulatory requirements. Provide and manage project specific trainings to the assigned team. Participate in Workflow, Operational/any client specific or other stakeholder meetings. Develop project specific WIs/Functional plans/Training plan for respective delivery, as per client specifications provided in SOW or by Program/Project manager. Prepare Deviation & CAPA for respective errors and ensure preventive measure are in place. Provide project specific performance feedback to the management and escalate issues in a timely manner. Advising staff on administrative policies and procedures, technical problems, and prioritization Provides oversight and guidance on organizational goals and company objectives Participate/Support in Audits and responsible for closing CAPAs on time. Participate in designated activities to support revision/creation of case processing procedural documents Read and acknowledge all necessary NLS and Sponsor's standard operating procedures as required. Participation in local or global project teams, including on-time delivery of assigned responsibilities Support on overseeing, improving, and contributing to procedures and performance Collaborate in the development, review, and initiation of SOPs Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects Mentors other staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion, and integrity, support Senior Management's leadership of both the department and the company Support oversight on operational activities and sound understanding on project plans/documents. Participate in team meetings and provide regular feedback to the management on operational metrics and other challenges/issues. Participate in trainings offered by NLS and sponsors and contribute to identification and implementation of process efficiencies. Liaise with mangers and in proactively identifying issues and proposing solutions. Providing technical reports, metrics, invoices, and support on new initiatives Delegating client requests and ensure it is addressed within the timelines. Contribute to achieve all SLA's agreed for both internal and external on the projects. Executes administrative operational tasks as required Perform other duties as assigned. Qualifications & competences: Life Science 8-10 years' experience in Pharmacovigilance Comprehensive medical knowledge Experience in the conduct of clinical trials and post-marketing PV Basic knowledge of medical coding (MedDRA / WHO-Drug Dictionary) Very good knowledge of written and spoken English Good knowledge of usual office software (MS Office Word, Excel, PowerPoint) Soft skills (motivation, strong communication competence, structured in work, or anisin skills, reliabilit commitment and ca acit for team-work
Responsibilities & functions: Clinical Research Associate Working in accordance with ICH E6 principles and with applicable SOPs (either ECRON AcuNova or Sponsor's SOPs) & local regulatory norms. Review of study synopsis. Site selection. Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM. Preparation, conduct and reporting of site selection visits. Negotiation & obtaining Investigator agreement on site budget, payment to the sites. Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents. Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner. Maintenance of TMF and Site specific file. Scanning & uploading documents into shared drive. Transmission of documentation into project files. Preparation of regulatory dossier, regulatory submission and follow-up. Preparation of EC dossier, EC submissions and follow-up. Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting. Development of meeting materials along with required presentations for investigators meeting. Site initiation visit planning, preparation, conduct, report and follow-up of pending issues. Co-ordinating the IP request between sites and pharmacist/vendor/sponsor. Site monitoring visit planning, preparation, conduct, report and follow-up of pending issues. Remote Monitoring, Central Monitoring and Risk Based Monitoring related activities. Accompanied visit as a part of mentoring a new CRA. Interacting with DM for data transfer and query resolution. Interacting with MW for CSR appendices. Preparation of project status report. Preparations, participation in meetings and documentation of meeting minutes. Provide oversight to project (maintaining quality & timelines of deliverables). Participate in client QA assessments. Reconciliation Filing of project correspondence. Site close-out visit planning, preparation, conduct, report. Maintenance of Investigator database and a QC of the database. Archival of study documentation. Participation in other department initiatives/activities.
FIND ON MAP