Clinical Research Associate

4 weeks ago

Vadodara, India Advanced Medtech Solutions Full time

Role & responsibilities

Participate in the investigator recruitment process. Perform initial qualification visits of potential investigators and sites. Evaluate the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.

Work with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.

Perform study initiation activities, reviewing with the site study team the protocol, regulatory issues, study procedures, and provide training on completion of the e-CRF; monitoring activities and study close-out activities.

Train site study team on the EDC system.

Conduct periodic site file audits to ensure compliance with GCPs and sponsors standard operating procedures.

Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.

Perform validation of source documentation as required by sponsor. Prepare monitoring reports and letters in a timely manner as per Clinical Trial Monitoring Plan.

Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records

Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture

Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Perform investigational product inventory. Ensure return of unused materials to designated location.

Review the quality and integrity of the clinical data through in house review of electronic CRF data and on-site source verification. Work with sites to resolve data queries.

Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.

Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).

Coordination with central and corelab (Echocardiography, QCA, OCT/IVUS, ECG) involved in the clinical trial.

Review protocols, eCRFs, ICF and other related documents, as requested by Project Manager.

Assist with final date review and query resolution through database lock.

Online & offline regulatory/IEC submissions of different countries.

Coordination with DSMB, Steering committee, CEC and attend meetings and prepare minutes of meetings.

Preparation of study presentation for review meetings at Central Drug Standard Control Organization Regulatory Body of India.

Preparation of Study presentation for national & international conferences.

  • [Only 24h Left] Clinical Research Associate

    7 days ago

    Vadodara, India Sun Pharmaceutical Industries Full time

    Job Title Clinical Research Associate Business Unit Clinical Research Location Bangalore At Sun Pharma we commit to helping you Create your own sunshine - by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world you ll...

  • Head Clinical Research

    2 days ago

    Vadodara, Gujarat, India Myonsite Healthcare Full time ₹ 8,00,000 - ₹ 25,00,000 per year

    Lead CRO (Clinical Research Organization) design & decentralized trial execution Build global partnerships with hospitals, labs & institutionsOversee Biospecimen collection, quality & complianceDrive B2C marketing & U.S. clinical research growth

  • Wanted Clinical Research Coordinator

    6 days ago

    Bengaluru, Mumbai, Vadodara, India Resolve Medicode Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Job Description:We are looking for a skilled and motivated Clinical Research Coordinator to join our team in Vadodara. The selected candidate will play a key role in managing and coordinating clinical research activities, ensuring smooth execution of clinical trials in line with GCP and regulatory standards.Key Responsibilities:Coordinate and oversee...

  • Clinical Trial Associate

    2 weeks ago

    Vadodara, Gujarat, India Ortolan Group Full time

    **Clinical Trial Associate** Vadodara or Mumbai, India (hybrid: 3 days office, 2 days home) **Salary**: Competitive + Benefits + Bonus If you are an agile, committed, and innovative clinical trial professional then we want to hear from you! Join us to help improve peoples' lives and make healthcare better for everyone! *** **Why...

  • Clinical Research Associate

    2 weeks ago

    Sevasi, Vadodara, Gujarat, India Anjna Hospital & Clinisearch Pvt.Ltd Full time

    Key Responsibilities 1. To obtaining Inform Consent Form. 2. To request and maintain accountability of all study related documents. 3. To check all study related documents for its legibility, accuracy and completeness. 4. To solve QA/RGA queries. 5. To conduct study initiation meeting. 6. To supervise all ongoing study procedures including screening,...

  • Clinical Research Coordinator

    4 days ago

    Vadodara, Gujarat, India Myonsite Healthcare Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    1–3 yrs clinical trial coordination (academia/industry). Strong ICH-GCP, protocol & regulatory know-how. Proficient with EDC, CTMS, eConsent, eTMF. Detail-oriented, problem-solver, excellent time management.

  • Research Associate

    2 weeks ago

    Vadodara, Gujarat, India krishna enterprise Full time ₹ 88,800 - ₹ 12,00,000 per year

    Research AssociatesLocation: Ekalbara (Padra)Industry: PharmaceuticalExperience: 1 to 5 YearsRequired Skills & Knowledge:Research Associate to support R&D activities including formulation, synthesis, or analytical development. The candidate will assist in conducting experiments, analyzing results, and maintaining accurate lab records. Responsibilities...

  • Senior Statistical Programmer

    3 weeks ago

    Vadodara, India Advanced Clinical Full time

    Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of...

  • QC reviewer

    2 days ago

    Vadodara, Gujarat, India Cliantha Research Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Experience: 2-4year experience in the clinical research in a quality control.Role & responsibilities1) Review of clinical raw data as per predefined Quality Control Plan for completeness, accuracy, and for compliance with the Study Protocol, GCP, SOPs and applicable regulatory Guidelines.2) Online Monitoring of study activities to ensure that studies are...

  • Research Associate

    3 days ago

    Padra, Vadodara, Gujarat, India krishna enterprise Full time

    We are seeking a motivated and detail-oriented **Research Associate** to support research and development activities in **Process Development (PD) Lab** and **Synthetic Chemistry Lab**. Hands-on experience in R&D - Synthesis/PD Lab of a pharmaceutical company. Collaborate with cross-functional teams. Operate and maintain lab equipment like reactors, vacuum...