Clinical Research Associate

Clinnex Research Pvt. Ltd.; Ahmedabad District; On-site; INR 350,000 - 600,000; Full time

Job summary

Clinnex Research Pvt. Ltd. is seeking a candidate for a role in Clinical Data Management. The responsibilities include coordinating with clients and third parties, entering and editing data from various documents, and supervising CRF design.

Applicants should have a Bachelor’s degree in life science, B. Pharma, or M. Pharma, or an equivalent combination of education and experience. Accurate record-keeping and quality control procedures are crucial for this position.

Qualifications

• Bachelor's degree, or educational equivalence, in life science/B. Pharma/ or M. Pharma equivalent combination of education, training and experience.

Responsibilities

• Coordinate between client and third-party contacts daily.
• Enter data from case report forms (CRFs) and questionnaires according to data entry conventions.
• Edit the database for correction of data entry errors.
• Supervise CRF design and assist in preparing DM Plan and DM Report.
• Prepare edit check plans and data entry conventions.

Education

Bachelor’s degree in life science/B. Pharma/M. Pharma

Job description

• To co-ordinate between client/any third party contacts within the project on a day to day basis.
• To enter data from case report forms (CRFs) and questionnaires and other project related documents as per data entry conventions of Clinical Data Management.
• To edit the database for correction of data entry errors.
• To perform and supervise CRF design.
• To assist in preparing DM Plan and DM Report.
• To prepare the edit check plan, data entry conventions, self-evident corrections.
• To review and clarify project data in accordance with the edit check plan.
• To carry out query production.
• To edit the database with answers to the data clarification forms (DCFs).
• To develop and validate the programs for comparing double data entry, listing individual data, applying edit checks etc.
• To be involved in development and maintenance of SOPs.
• To file study documentation.
• To implement defined quality control procedures as per DM Plan.
• To record all activities accurately on the company standard timesheet.

Preferred Qualifications:

• Bachelor’s degree, or educational equivalence, in life science/B. Pharma/ or M. Pharma equivalent combination of education, training and experience.