Premier Research is looking for a Site Solutions Executive (PRI) to join our India Operations team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. Location: Nagpur. This is a contract position with a duration of 1 year. What You ll Be Doing: Coordinates and facilitates all Clinical trial activities at site ensuring compliance with protocol, applicable GCP guidelines and local regulations; Supports Principal Investigator (PI) and site study team assuring that the clinical trial(s) being conducted meet all the criteria set by the sponsors and regulators, Reviews the site processes, identifies gaps and supports roll-out of site processes. The following key functions are required routinely: Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/Investigator Maintaining clinical trial-related documents at site including Trial Master File. Preparing for, facilitating and assisting at site initiation, monitoring and close-out visits protocol-prescribed and other necessary patient-visits, QA visits, sponsor visits and Inspections. Reporting site-performance metrics at pre-determined frequency. Coordinating submissions to ethics committee of protocol, adverse events and periodic study reports for review and ensuring that all documentation to and from ethics committee is appropriately maintained. Assisting in scheduling patient investigations and assessments per instructions of Principal Investigator Ensuring timely availability of IP and Lab kits and other clinical trial supplies and ensuring IP is appropriately stored, maintaining temperature logs where necessary; also maintaining IP accountability and accurate record of all clinical trial supplies including lab kits; dispensing of IP to subjects per the protocol under the supervision of the PI Assuring that all work at site prescribed by the approved protocol, the contract and the EC is performed in a timely and comprehensive manner Organizing and coordinating laboratory sample pick-ups and reporting Transcribing source documents if required under the supervision of the PI or designated person and ensuring that they are reviewed and signed off by the responsible person. Assisting in timely resolution of data queries Coordinating and supporting timely completion of protocol-related procedures by the PI, specifically subject scheduling, subject screening and enrolment Maintaining regular contact with site monitor regarding patient enrolment, visit scheduling, dosing/dispensing Facilitating cordial and timely communication between investigator and sponsor/CRO - Supporting patient-awareness, training or other events at site or in the neighborhood Supporting data collection activity at site including but not limited to feasibilities, epidemiological data To create the database of potential patients that can be enrolled into the study as per the protocol To identify any challenges and find out mitigation plan in advance with the support of LM, TSM & PI Responsible to complete all mandated training and ongoing training modules and SOPs Responsible for notifying Sponsor / CRO representatives of external audits/ inspections by the sponsor and regulatory authorities respectively. Collaborates with PI to respond to any audit findings and implement approved recommendations. Escalate systemic non-compliance and/or misconduct to his /her manager for appropriate follow-up. Directs all feasibilities coming to the site to feasibility team at CS. What we are looking for: A Bachelor s or Master s degree in clinical, biological or mathematical sciences or related fields, or a medical or dental degree or a nursing qualification; Exceptions to this would require a minimum of 4 years of experience of working at clinical research sites. Good oral and written communication skills in English and at least one local Indian language Excellent interpersonal skills Good coordination and organizational skills and also problem-solving and analytical skills Attention to detail and documentation and conscious of the importance of time and data accuracy in the clinical trial context Conscious of ethical and scientific requirements and of patient-safety and patient-rights in the clinical trial context Familiarity with computer usage and office communication tools
Premier Research is looking for a Medical Specialist to join our Medical Affairs team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What youll be doing: The Medical Specialist (MPs) is responsible for supporting members of the medical team (i.e. Medical Monitors (MM), Medical Scientists (MS), and other functional leads) to perform and execute all project deliverables associated with a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements. Partners with the MM and MS across all therapeutic areas at Premier Research to support overall project delivery through coordination and oversight of broad study needs. This may include tracking of safety data, document maintenance in accordance with applicable study regulations (including keeping document logs and collections) and providing planning and scheduling assistance for internal and external activities, and FDA regulated documentation. Independently responsible for managing and overseeing the 24/7 staff physician tracker and process in accordance with FDA regulation, including: managing vendor relationship, liaising with associated therapeutic area/BU, conducting test calls, maintaining associated SOPs, triaging medical information. Collects study-specific data reports, compiling specified documents, and modifying Premier Research-approved templates to study-specific and protocol needs. Provides document formatting and the display of select data/information or summaries, as needed. Assists with 21 CFR Part 11 document compliance and facilitates document handling for the MM, as well as tracks and supports the capture of these documents into the Trial Master File (TMF). Supports other activities for TMF documents for the medical team under specifications of the MM. Provides project template customization including Word documents and PowerPoint slide decks to the specification of the medical team. Develops and independently maintains tracking tools for select safety concerns to the specifications of the lead MM for individual studies, as well as tracking of study participants during the pre-enrollment eligibility process (PEER) as applicable. Assists with the Data Monitoring Committee/Data and Safety Monitoring Board/Safety Review Committee (DMC/DSMB/SRC) meeting planning and preparations for the medical team, following the specifications of and under the supervision of the MM/MS, and supports recurring medical data reviews and DMC/DSMB meetings with document collection and distribution to MM/MS. Supports all therapeutic areas in the setup, development, and maintenance of study specific data displays using Clinical Trial Management Software. Assists MM/MS in facilitating team communications and maintaining documentation internally and externally. Ensures effective communication by scheduling internal and external team meetings. Develops and independently maintains Medical Affairs team study tracker, proactively identifies gaps, and promptly alerts the MM/MS teams to critical issues. Acquires additional information and skills to enhance job performance, maintain an up-to-date knowledge of Premier Research systems, services, policies and procedures. Participates in corporate initiatives and actions that ensure the continued success of the company. What we are looking for: Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field and a minimum of 2 years of clinical research experience or Bachelor s degree, or international equivalent, preferably in a clinical, biological, scientific, business, or health-related field, and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred. Strong computer skills in MS office suite required. Basic knowledge of ICH/GCP regulations. Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures. Basic knowledge of project management terminology and guidelines a plus.
Premier Research is looking for a Data Manager - FS to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What youll be doing: Assists in preparing clean databases by performing a review of clinical trial data through the CDMS or external data listings to ensure all captured data follows the rules outlined by the protocol and Data Management Plan Provide input to and review of Data Management Plans in support of clinical study deliverables Generates queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates, and client representatives) to resolve problematic data identified during every aspect of the data management process Reviews responses to queries for appropriateness, resolves any discrepancies, and modifies the database accordingly Supports the development of CRFs and edit check specifications per protocol and participates in user acceptance testing of CRFs and associated edit check specifications as required What we are searching for: Bachelor degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field], or equivalent combination of education, training and experience 3 to 5 years of practical experience using commercial clinical data management systems and/or EDC products (eg - Oracle RDC / Inform, Medidata Rave, DataLabs, etc). Alternately, must have proven experience in all primary job functions. Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc)