
Clinical Research Associate
15 hours ago
Overseeing the management of clinical trials across the site to ensure they progress in accordance with contract terms and defined quality standards protocols SOPs GCP and relevant guidelines to meet local regulations Communicating project scope timelines goals technical details and input from the Director Project Manager to the sites throughout the project Support HOD Project Manager in operational inputs for the conduct of study Support in investigator payments and other vendor payment Conduct Feasibilities document and maintain them including trackers if any as per SOPs and under the supervision of PM Designee Assisting the Project Manager in developing the project plan monitoring plan and other documents as per the requirements of the project and sponsor Identifying categorizing evaluating and updating the potential Investigators and Vendor list with CTA Performing Site Initiation visits to ensure that each site has the necessary trial materials Ensure the report and follow-up letter are sent to the site with the timelines and follow-up for pending queries or issues as per agreed timelines Preparing completing the checklist for site activation ensuring IMP readiness Conducting interim monitoring visits to assess protocol adherence monitoring plan compliance and the protection of human rights This includes source data verification CRF collection IP accountability and report preparation The MV report and follow-up letter should be finalized within the agreed timelines and pending queries or issues to be followed up effectively for closure as per agreed timelines Review of protocol e-CRF Lab Manual Informed Consent Form and all other project-specific documents to familiarize and manager site management effectively During monitoring visits ensure that the sites are notified and subsequently notify EC Verify the cross-notification process for SAE as per the CDSCO checklist both to the DCGI on behalf of the sponsor and to the other participating sites Regular Review of PSSV SIV SMV reports for timely closure of issues Assuring readiness of Logs Laminates and File indexes for the organization of document and presentations for training Preparing and submitting the study dossier to the Ethics Committee and sites Preparation and review of responses to QA audit and sponsor audit observations Conduct Site Close-out Visits as per SOP and responsible for ensuring data query resolution updated site files study files investigational product reconciliation etc Circulating the final study report to the respective sites for Ethics Committee notification and archival Follow-up with sites for patient recruitment patient follow-up activities required to perform as per protocol and resolution of issues Coordinate and distribute clinical study material to study sites Assisting with investigator meetings including preparation liaison presentations and follow-up Maintaining the trial master file or electronic TMF and other applicable checklists or documents as per SOP including reported Adverse Events annual IEC IRB reports EC Communications and Correspondence All TMFs eTNFs to be ready for audit or inspection all the time Supervise Train and mentor CRAs CTAs or other CO staff Preparing the project for archival as specified in the contract upon study Individual Training Files to be up-to date and always audit ready Ensure study data is entered in study specific EDC tools and reviewed as per the protocol and other relevant documents and ensure all queries are resolved within the specified timeline for data cleaning and database lock PSSV SIVs SMV and SCVs will be performed along with other experienced CRAs Designee as a part of CRA Training Performing these visits independently is upon approval of HOD Ensure Sites are audit or inspection-ready all the time and assist in audit inspection readiness and in CAPA as necessary Support departmental vendor assessment and planning etc Contribute to the development of Standard Operating Procedures SOPs and working practice Familiarize with ICH-GCP appropriate regulations relevant SOPs and internal tracking systems Willingness to travel for job-related activities Expected Travel Responsible for maintaining and keep up to date employee training file Fulfilling other duties as assigned by HOD CEO Job Type Full-time Pay 350 000 00 - 600 000 00 per year Education Master s Preferred Experience Clinical research 2 years Preferred Work Location In person
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Clinical Research Associate
6 days ago
Gandhinagar, India Eccentric Clinical Research Pvt Ltd Full timeOverseeing the management of clinical trials across the site to ensure they progress in accordance with contract terms and defined quality standards, protocols, SOPs, GCP, and relevant guidelines to meet local regulations. Communicating project scope, timelines, goals, technical details, and input from the Director/Project Manager to the sites throughout...
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Faculty – Clinical Research
6 days ago
Malappuram, KL, IN Clinomic Center for Clinical Research Full timeJob Title Faculty - Clinical Research Location Mallapuram Kozhikode Department Academics Clinical Research Employment Type Full-Time Reporting To Academic Head Director About the Role We are seeking an experienced and passionate Faculty Member in Clinical Research to join our academic team The ideal candidate will bring a strong foundation in Pharmaceutical...
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Quality Assurance Auditor
1 week ago
Gandhinagar, India Eccentric Clinical Research Pvt Ltd Full time**Job Summary** We are seeking a Quality Assurance Auditor to join our reputable Contract Research Organization (CRO) and be responsible for ensuring the highest standards of quality and compliance in our clinical research activities. In this crucial role, you will play a key part in maintaining regulatory compliance, conducting audits, and driving...
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Ahmedabad, Gandhinagar, India Brillex Clinical Research Pvt. Ltd. Full time ₹ 5,00,000 - ₹ 12,00,000 per yearRole & responsibilitiesResponsible for clinical trial medical science related activities like preparation of protocol, Informed consent form, CRF, other study related documents and SOPs in line with ICH GCP, Indian and global regulatory.Conduct relevant literature search for required for protocol and manuscript writing.Ensures that medical writing...
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Ahmedabad, Gandhinagar, India Brillex Clinical Research Pvt. Ltd. Full time ₹ 12,00,000 - ₹ 36,00,000 per yearRole & responsibilitiesDevelop and manage comprehensive project plans, including timelines, budgets, resource allocation, and risk mitigation strategies.Oversee all aspects of trial startup, including site selection, contract negotiation, IEC/IRB submissions, and study team training.Monitor trial progress against established milestones and timelines,...
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Clinical Research Administrator
4 days ago
Kollam, KL, IN Amrita University Full timeAmrita Vishwa Vidyapeetham Amritapuri Campus is inviting applications from qualified candidates for the post of Clinical Research Administrator For Details Contact hr provostoffice amrita gmail com Job Title Clinical Research Administrator Location kollam kerala Required Number 1 Qualification PharmD Job description Coordinate communication schedule and...
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Research Associate
2 weeks ago
Gandhinagar, India Arthan Careers Full timeGandhinagar, **Description**: - Led by visionary Indian leaders Mr Deepak Parekh Chairman HDFC, Mr Sudhir Mehta, Chairman Torrent Group, Mr Anand Shah Co-founder Ola-electric and Dr Hasmukh Adhia, ex Finance secretary, GOI; SOUL aspires to create a new era of bold and purposeful leadership and aims to empower promising young leaders working in the areas of...
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Medical Monitor
1 week ago
Ahmedabad, Gandhinagar, India Brillex Clinical Research Pvt. Ltd. Full time ₹ 12,00,000 - ₹ 24,00,000 per yearJob SummaryThe Medical Monitor will serve as the primary medical expert for late-phase (Phase IIIV) clinical trials, ensuring subject safety, scientific integrity, and regulatory compliance throughout the study. This role involves providing ongoing medical oversight, safety data review, protocol compliance assessment, and guidance to investigators and the...
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Junior Research Associate
1 week ago
Dahegam, GJ, IN EaseBiz Placement Full timeDesignation - Junior Research Associate - Organic Chemistry Location - Kadadra Dehgam Gujarat Experience Required 6 months to 2 years Salary - 20 k to 30 k Depend on interview Qualification M Sc in Organic Chemistry Timing - 9 00 AM to 7 00 PM Weekly off - Monday Key Responsibilities Perform organic synthesisof intermediates and target compounds as per...
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Associate Professor
2 days ago
Gandhinagar, GJ, IN Dhirubhai Ambani Institute of Information and Communication Technology Full timeCandidates must have a Ph D in Electronics Engineering or an allied area from a reputed institution and a good research record and background The following sub-areas are currently of interest Circuits Electronics VLSI Technology Analog circuits Mixed mode ICs Semiconductor Devices Embedded Systems Edge Computing Real Time Operating Systems Side Channel...