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We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team at Thermo Fisher Scientific. As a CRA, you will be responsible for ensuring the integrity and quality of clinical trials, while providing exceptional customer service to our clients.
Key Responsibilities- Conduct site initiation visits, monitoring visits, and close-out visits to ensure compliance with regulatory requirements and study protocols.
- Verify and document site qualifications, including facility, equipment, and personnel.
- Monitor and report any deviations or issues related to the study protocol or regulatory requirements.
- Collaborate with site personnel to resolve any issues or concerns related to the study.
- Provide training and support to site personnel on study protocols and regulatory requirements.
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent.
- Minimal clinical monitoring experience (comparable to 2 years) in a clinical environment.
- Valid driver's license where applicable.
- Knowledge of ICH GCPs and applicable regulations and procedural documents.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Good organizational and time management skills.
- Ability to remain flexible and adaptable in a wide range of scenarios.
This role requires frequent travel (60-80%) and may involve extended overnight stays. You will be exposed to biological fluids and may be required to wear personal protective equipment.
Physical Requirements- Ability to work in an upright and/or stationary position for 6-8 hours per day.
- Repetitive hand movement and frequent mobility required.
- Occasional crouching, stooping, and bending.
- Light to moderate lifting and carrying of objects (up to 15-20 lbs).