Name of the position: Senior CRA

Number of vacancies: 01

Location: Ahmedabad- WFH

Years of Experience: 03- 06 years

Job Description:

- Preparing & reviewing SOPs,
- Reviewing protocol and related documents,
- Identifying potential Investigator sites,
- Maintaining the database of the Investigator site,
- Conducting site selection and initiation,
- Conducting close-out visits,
- Training investigator and related site staff on the study protocol,
- Responsible for vendor selection,
- Responsible for ensuring clinical trial supplies at the sites,
- Accountability for clinical trial supplies,
- Reviewing the source data and maintaining the integrity and quality of the trial,
- Reporting any event to superiors in case of non - compliance,
- Preparing and circulating the monitoring reports,
- Ensuring the observations are closed and adhering to the protocol requirements,
- Coordinating with other departments like CDM, statistics, and QA to ensure all the data-related observations are closed,
- Reviewing of reports,
- Ensuring all the AES, SAES, deviation, etc are reported to the authority on time as required.
- Review study protocols and contribute to the design and review of electronic Case Report Forms (eCRFs), edit checks, and clinical databases.
- Review clinical trial data for accuracy, integrity, and compliance with study protocols, SOPs, client requirements, and regulatory guidelines.

Required Qualifications

- Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related discipline.
- 3-5 years of experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology environment.




- Experience working with Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle InForm, Veeva EDC, or similar platforms.
- Good understanding of clinical trial processes, database management, and data cleaning methodologies.
- Knowledge of ICH-GCP, CDISC (CDASH/SDTM), and regulatory guidelines.
- Proficiency in Microsoft Excel and Microsoft Office applications.

Required Skills

- Strong analytical and problem-solving skills.
- Excellent attention to detail and commitment to data quality.
- Effective verbal and written communication skills.
- Ability to manage multiple studies and prioritise competing deadlines.
- Strong interpersonal and cross-functional collaboration skills.

Preferred Qualifications

- Experience supporting Phase I–IV clinical studies.
- Exposure to data reconciliation, external data management, and medical coding processes.
- Valuable to have Certification in Clinical Data Management or Clinical Research is desirable.
- Good to have a knowledge of oncology trials.

Note :Please apply, candidate those who have experience and from Clinical Research background

Pay: ₹400,000.00 - ₹800,000.00 per year

Ability to commute/relocate:

- Ahmedabad, Gujarat: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Application Question(s):

- Do you have experience or exposure in Data Designing?

Education:

- Master's (Preferred)

Experience:

- Clinical Research Associate: 3 years (Required)
- Clinical Data Review: 3 years (Preferred)
- working with EDC Platform: 1 year (Required)

Location:

- Ahmedabad, Gujarat (Required)

Work Location: In person

📌 Senior Clinical Research Associate (Ahmedabad)
🏢 GSC Technolabs Private
📍 Ahmedabad