Are you passionate about clinical research and committed to maintaining the highest standards of patient safety, data integrity, and regulatory compliance?
We are looking for a
Clinical Research Associate (CRA)
to join our Clinical Operations team. The ideal candidate will play a key role in ensuring the successful execution of clinical trials by managing compliance, site coordination, data management, and ethical oversight. This role involves collaborating with investigators, sponsors, and regulatory bodies to maintain protocol adherence, patient safety, and GCP compliance while overseeing study logistics and documentation.
Key Responsibilities
1. Regulatory Compliance:
· Ensure compliance with general and study specific regulatory requirements
· Conduct study activities in alignment with local, federal, and state regulations and institutional policies.
· Submission of EC Dossier and coordination with IEC/IRB to get approvals for the Clinical Trial Conduct.
2. Site Management:
· Coordinate and execute site selection, initiation and close-out visits.
· Conduct training for site staff on trial-specific industry standards and procedure.
3. Study Coordination:
· Facilitate daily clinical trial activities, including scheduling study subject appointments and serving as a liaison between patients, principal investigators (PIs) and other study personnel.
· Support the informed consent process by clearly communicating study protocols and answering questions from potential subjects.
4. Participant Management & Communication:
· Facilitate explicit and effective communication with CROs, sponsors, investigators, research teams, laboratories, and vendors.
· Serve as the primary contact for study-related inquiries from sponsors, and regulatory authorities.
5. Data Management:
· Maintain and manage study records, inclu
📌 Clinical Research Associate (Bengaluru)
🏢 TrialGuna Private
📍 Bengaluru
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.