Clinical Research Associate

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:

Bachelor's (Required)

Experience:

Clinical research: 3 years (Preferred)

Language:

English Proficiency (Preferred)

Location:

Ahmedabad, Gujarat (Required)

Willingness to travel:

25% (Required)

Work Location: In person