Clinical Research Associate

3 weeks ago

Ahmedabad, Gujarat, India Biotech Healthcare Full time
Role Objective:

A key objective of this position is to support clinical trials by ensuring compliance with regulatory guidelines, coordinating with trial sites, and managing essential documentation. The incumbent will assist in the preparation, submission, and follow-up of clinical trial-related documents while ensuring the smooth execution of study protocols.

Desired Candidate Profile:
Bachelor's degree in optometry

,

pharmacy, clinical research and pharmacology with a strong foundation in clinical research.
0–1 year

of experience in clinical trial processes, including data collection, management and regulatory compliance.
Strong analytical and problem-solving skills, particularly in handling data queries and discrepancies.
Effective communication and collaboration skills.
Ability to liaise with investigators and support site operations efficiently.
A proactive approach to improving clinical processes.
Team player with excellent coordination abilities.

Role and Responsibilities:
Regulatory & Ethics Committee Coordination:
Prepare, submit and coordinate Ethics Committee and regulatory dossiers for clinical trials at multiple sites.
Ensure timely registration of clinical trials on regulatory platforms as per local regulations.
Apply for protocol amendments and additional site notifications to regulatory agencies.

Clinical Trial Site Management:
Set up trial sites by ensuring all necessary materials, including the investigational medicinal product (IMP), are available.
Collect and manage Case Report Forms (CRFs) from study sites.
Conduct timely site visits, including site initiation, routine monitoring and site close-out.
Perform source data verification and manage site queries.

Investigational Product & Supply Management:
Order, track, and manage investigational products and trial materials.
Ensure compliance with Standard Operating Procedures (SOPs), local regulations, and ICH-GCP guidelines.

Coordination and Reporting:
Coordinate with clinical trial sites and liaise with investigators for trial execution.
Ensure timely data collection from sites for ongoing projects.
Escalate and resolve any site-related issues.

Additional Responsibilities:
Support in the preparation of investigator agreements and identification of new investigators.
Assist in other clinical operations tasks as assigned.

Functional Skills Required:
Understanding of clinical trial processes, regulatory requirements, and compliance standards.
Knowledge of Good Clinical Practice (GCP) and local clinical research regulations.
Proficiency in managing clinical trial documentation and ethics committee submissions.
Ability to conduct site monitoring visits and oversee data verification processes.

Behavioral Skills Required:
Strong communication and interpersonal skills.
Attention to detail and problem-solving abilities.
Ability to work collaboratively within a team.
Proactive and self-motivated approach towards process improvements.
Adaptability and ability to manage multiple tasks efficiently.

Team Size to be Handled:
Individual contributor role, reporting to Manager - Clinical Opration.

Important Links:
Website:
LinkedIn:
Instagram:

Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

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