Crestenroll Technologies Hiring for Hiring Freshers for Clinical Research Associate (CRA) at Pune Full Time

Job Description :

We are looking for an organized, flexible clinical research associate to oversee clinical trials. The clinical research associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The clinical research associate will manage multiple aspects of the subjects’ welfare. You will conduct regular site visits, generate and distribute internal and external newsletters, prepare final reports, and liaise with interested parties regarding all trial aspects. You will play a leading role in generating and overseeing documentation and records.

Roles and Responsibilities :

• Creating and writing trial protocols, and presenting these to the steering committee.
• Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
• Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
• Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
• Ordering, tracking, and managing IP and trial materials.
• Overseeing and documenting IP dispensing inventory, and reconciliation.
• Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
• Conducting regular site visits, coordinating project meetings, and writing visit reports.
• Implementing action plans for sites not meeting expectations.
• Liaising with regulatory authorities.
• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Other tasks and responsibilities as needed.

Required Skills :

• Bachelor’s degree in biological science or a related field.

(B.Pharm/M.Pharm/ Pharm D/ MBBS/ BDS/ BAMS/ BHMS/ MD/ MDS BSc/MSc in Biotech, Chemistry, Botany, Zoology, Biochemistry, Microbiology)

• No work experience required
• Strong verbal and written communication skills.
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Ability to manage and prioritize workload effectively.

Job Types: Full-time, Regular / Permanent, Fresher

Salary: ₹18,000.00 – ₹25,000.00 per month

Benefits:

• Cell phone reimbursement
• Commuter assistance
• Flexible schedule

Schedule:

• Day shift
• Flexible shift

Supplemental pay types:

• Performance bonus
• Yearly bonus

Ability to commute/relocate:

• Pune, Maharashtra: Reliably commute or planning to relocate before starting work (Required)

Language:

• English (Preferred)