Senior Clinical Research Associate (Senior CRA)
Location: [Not Specified]
Experience: 3+ years
Job Type: Full-Time
Job Overview:
We are seeking a Senior Clinical Research Associate (Senior CRA) to join our expanding clinical operations team. The role is pivotal to the successful setup, execution, and closure of clinical trials, ensuring that they are conducted in full compliance with ICH-GCP, SOPs, and applicable regulatory requirements. The Senior CRA will collaborate with cross-functional teams, investigators, and sponsors while providing support to project managers and acting as a key point of contact for clinical sites.
Key Responsibilities:
Study Start-Up & Site Selection:
Conduct feasibility assessments and site selection visits
Negotiate and facilitate execution of site/investigator contracts
Assist in the setup of the Trial Master File (TMF)
Contribute to the development and local adaptation of study-specific documentation
Facilitate regulatory submissions and approvals
Study Conduct & Monitoring:
Conduct site initiation, monitoring, and closeout visits
Maintain regular communication with site staff and internal project teams
Ensure adherence to protocol, GCP, and regulatory guidelines
Support site issue resolution and escalate to the Project Manager when necessary
Retrieve Case Report Forms (CRFs) and ensure timely query resolution
Ensure proper documentation within the TMF throughout the project lifecycle
Project Support & Communication:
Provide project updates to Project Manager/Project Team Lead
Participate in investigator meetings, client calls, and internal team discussions
Act as a back-up to the PM/PTL as needed for client and vendor communications
Assist in project closeout activities and site closure documentation
Candidate Profile:
Education: Degree in Life Sciences, Pharmacy, Nursing, or related field
Experience:
Minimum of 3 years of on-site monitoring experience in clinical trials
Proven experience in all phases of trial conduct including initiation, monitoring, and closeout
Knowledge & Skills:
Strong understanding of ICH-GCP guidelines and local regulatory requirements
Excellent written and verbal communication skills
Proficient in TMF management, CRF tracking, and query resolution
Effective time management and organizational abilities
Ability to work independently and as part of a team
Estimated Salary: ₹8 – ₹14 LPA (depending on experience and sponsor model)
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