Position: Clinical Research Associate (CRA)
Number of Openings: 01
Location: Ahmedabad- WFO
Job Responsibilities
- Prepare, review, and maintain Standard Operating Procedures (SOPs).
- Review study protocols, informed consent forms, and other essential clinical trial documents.
- Identify, evaluate, and maintain a database of potential investigator sites.
- Conduct site selection, site initiation, monitoring, and close-out visits in accordance with study timelines and GCP guidelines.
- Train investigators and site personnel on study protocols, trial procedures, and regulatory requirements.
- Coordinate vendor selection and oversee vendor-related activities.
- Ensure timely availability, distribution, reconciliation, and accountability of clinical trial supplies at investigational sites.
- Perform source data verification (SDV) and ensure data accuracy, integrity, and compliance with study protocols and regulatory requirements.
- Monitor protocol compliance and promptly report any non-compliance or significant issues to the appropriate stakeholders.
- Prepare, review, and circulate monitoring visit reports within defined timelines.
- Follow up on monitoring observations and ensure timely resolution of action items.
- Collaborate with cross-functional teams, including Clinical Data Management (CDM), Biostatistics, and Quality Assurance (QA), to resolve data queries and study-related observations.
- Review study documentation and reports to ensure quality and regulatory compliance.
- Ensure timely reporting and documentation of Adverse Events (AEs), Serious Adverse Events (SAEs), protocol deviations, and other safety-related events in accordance with applicable regulatory and sponsor requirements.
Eligibility Criteria
- 1–3 years of experience as a Clinical Research Associate (CRA).
- Candidates with 2+ years of experience as a Clinical Research Coordinator (CRC) are also encouraged to apply.
- Excellent written and verbal communication skills.
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
- Ability to work independently while collaborating effectively with cross-functional teams.
Pay: ₹20,000.00 - ₹30,000.00 per month
Ability to commute/relocate:
- Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)
Application Question(s):
- What is your notice Period?
- How frequent you can join?
- Are you comfortable with Suggestive Salary Band?
Education:
Experience:
- Clinical research: 3 years (Preferred)
Language:
- English Proficiency (Preferred)
Location:
- Ahmedabad, Gujarat (Required)
Willingness to travel:
Work Location: In person
