Fortrea, a leading global Contract Research Organization (CRO), offers a broad spectrum of clinical development and technological solutions to pharmaceutical, biotechnology, and medical device companies. With a commitment to scientific excellence and patient-focused innovations, Fortrea operates across more than 90 countries, employing over 19,000 dedicated professionals. Their mission is to transform drug and device development, bringing life-saving therapies to patients around the world more efficiently.
If you’re passionate about clinical research and looking to be part of a team that’s driving innovation, the Clinical Data Coordinator I role in Mumbai, India, is an exciting opportunity to explore.
Key Responsibilities as a Clinical Data Coordinator I at Fortrea
As a Clinical Data Coordinator I, you’ll play a crucial role in managing external data to ensure accuracy and compliance with study protocols. Here are some of the main responsibilities:
- Ensure that electronic vendor data contains all protocol-specified parameters, is formatted correctly, and is accurately populated into the relevant fields for each patient.
- Support the Lead Data Manager (LDM) in developing Data Transfer Agreements and Data Transfer Specifications for vendor data transfers.
- Review discrepancies generated by study-specific edit checks and perform query management to resolve data issues.
- Assist in validation reviews of electronically transmitted data, ensuring proper loading for a sample of the total study patients.
- Interact with Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs) to gather and verify local laboratory normal ranges for all study sites.
- Perform quality control checks on local laboratory data and ensure accurate data entry into the system.
- Collaborate with vendors and clients to resolve data transfer issues, with initial oversight from more experienced staff.
Qualifications Required for the Role
To succeed as a Clinical Data Coordinator I at Fortrea, the following qualifications are required:
- A university or college degree in life sciences, health sciences, information technology, or a related field.
- A certification in allied health professions from an accredited institution is also acceptable.
- At least 3 years of prior experience in the pharmaceutical, biotechnology, medical device, or clinical trial industries, or an equivalent combination of education and experience.
Skills Needed for the Position
The ideal candidate for this role should have:
- Strong problem-solving skills and the ability to handle data discrepancies.
- Excellent attention to detail to ensure data accuracy and compliance.
- Good communication skills to interact with clinical staff, vendors, and clients.
- Ability to work independently and collaboratively within a team environment.
- Proficiency in data management and familiarity with clinical trial processes.
