10 Site Initiation Jobs

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Site engineer required(LT/HT) required for gujrart kuchch location Qualification- Any electrical Exp- min 5 yrs salary- upto 40k Wtsapp me resume at 8295842337- Mr. Bansal

YOUR TASKS AND RESPONSIBILITIES: Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers Oversee & document IP dispensing, inventory management & reconciliation Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated Investigator and site personnel training on the Study protocol, procedures, and GCP principles Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL WHO YOU ARE: Minimum qualification requirement is to have a Bachelor's or Masters degree in a health[1]related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Relevant experience of 1-5 years minimum in the field of Clinical Research Job Locations: Mumbai, Pune, Chennai

YOUR TASKS AND RESPONSIBILITIES: Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers Oversee & document IP dispensing, inventory management & reconciliation Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated Investigator and site personnel training on the Study protocol, procedures, and GCP principles Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL WHO YOU ARE: Minimum qualification requirement is to have a Bachelor's or Masters degree in a health[1]related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Relevant experience of 1-5 years minimum in the field of Clinical Research Job Locations: Kolkata, Bhubaneswar, Delhi

Onsite monitoring experience for phase II / III / IV studies, visit experience including exposure of SIVs, MVs & CVs. Assisting Project Manager in entire day to day activities Required Candidate profile Good communication skills Minimum 2+ years of onsite monitoring visit experience as CRA must. Good knowledge of GCP & schedule Y.

Site execution of high rise buildings Have good skills in project management and administration including documentation Contract management and contractors' coordination Good presentation skills - experience in complete project management " Required Candidate profile "Have experience in working as PMC. Experienced in designing the various large-scale projects like residential - commercial - hospital - master planning, Timely completion of Projects execution

Role & responsibilities Study start-up: Site feasibility assessment, Site evaluation/selection, Site / Investigator financial & study contract execution, Prepare EC submission packages. Site management & clinical study monitoring : Site initiation & liaison Ing, Site staff training / re-training, Oversee sites on patient recruitment, Patient retention etc., Site recruitment issue/trouble-shooting, Study monitoring, Source data verification/ensure \ data quality, Support site audits, Site close out Management of clinical trial supplies Vendor management Project management : Tracking timelines & budget, Site & vendor invoice payments, Coordinate with cross functional teams Preferred candidate profile M.Sc / M. Pharma with relevant CRA experience of 2-7 Years Interested Candidates can share their CVs on vilshashah@torrentpharma.com

Role & responsibilities : Manage, design, develop, create and maintain small-scale through to large-scale construction projects in a safe, timely and sustainable manner Site Management with Complete Site Responsibility Conduct on site investigations and analyze data (maps, reports, tests, drawings and other) Assess potential risks, materials and costs Provide advice and resolve creatively any emerging problems/deficiencies Oversee and mentor staff and liaise with a variety of stakeholders Handle over the resulting structures and services for use Monitor progress and compile reports in project status Manage budget and purchase equipment/materials Preferred candidate profile : Candidate should have experience in Road Construction & Level Machine

Dear Candidate, CBCC Global Research is looking for CRA/Sr. CRA with onco PK experience Job Code : CBCC/IND/CRA (Please mentioned job code in subject line of your application ) Work Experience: 3-8 Years Monitoring experience with Oncology PK studies is mandatory Work Location: Bangalore, Hyderabad, Pune Pre-Requisite Skills: Minimum 2 years onsite monitoring experience mandatory Patient base PK studies monitoring experience is preferred Key Responsibilities Overall site management of clinical trials and Patient base PK studies Ensure effective communication to sites Prepare for site visits Assist PM in developing the project plan Prepare the Site Activation checklist Handle back-office monitoring/centralized monitoring Coordinate with sites for resolving DCFs Other duties as assigned by PM, Head-PM, and DO Technical Experience Awareness about current regulation guidelines (GCP, NDCT rule, COVID guidance, RECIST, USFDA/EMA guidance etc.) Strong therapeutic knowledge for better handling of current studies Understanding of the ethics committee and informed consent form requirements Awareness about AE/SAE/deviations in submission and documentation requirements Awareness about phase trials, BA/BE studies and trial-related setups, instruments, staff and other site requirements Awareness about site selection requirements, aspects of (onsite/remote) monitoring, and knowledge about indication-specific good sites pan-India and handling site issues Awareness on issues during patient recruitments and the ability to effectively overcome those issues Awareness about the EDC platforms, IP handling requirement and its importance Please apply at career@cbcc.global. Important Note : Freshers are not eligible for this opening, those who are having relevant experience as mentioned above can apply for this opening .

We are looking for a proactive and experienced Site Supervisor with a strong background in infrastructure works and construction activities. The Site Supervisor will assist the Engineer in the day-to-day operations on site, ensuring that the Villa and row house construction activities, including infrastructure works and building construction, are carried out efficiently and safely. Key Responsibilities: Supervise and manage construction activities on-site, ensuring compliance with safety regulations and building codes. Coordinate with project managers, engineers, and subcontractors to ensure smooth operations. Conduct regular site inspections to monitor progress and quality of work. Maintain accurate records of project activities, including daily reports, attendance, and material usage. Ensure that all safety protocols are followed and promote a safe working environment. Resolve any on-site issues or conflicts that arise promptly and effectively. Assist in the training and development of site staff. Ensure that materials and equipment are available as needed and properly utilized. Communicate with clients and stakeholders regarding project updates and progress . Coordinate the delivery, storage, and usage of construction materials to avoid delays and ensure proper stock management. Maintain accurate and up-to-date records of site activities, daily logs, worker attendance, and work progress reports. Key Requirements: Education: Diploma or B.E in Civil Engineering, Construction Management, or a related field. Minimum of 6 years of experience in supervising in infrastructure and building construction, specifically with experience in villas or row house or building construction . Familiarity with construction processes, infrastructure works and the ability to read and interpret construction drawings and specifications. Strong problem-solving skills with the ability to resolve on-site issues swiftly. High attention to detail, ensuring all aspects of construction meet quality and safety standards.