Clinical Monitoring Specialist
hace 5 días
Company Overview
As a leading global contract research organization (CRO), Fortrea is dedicated to providing pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development solutions across more than 20 therapeutic areas. With operations in over 90 countries, we are transforming drug and device development for partners and patients worldwide.
Job Description
We are seeking an experienced Clinical Monitoring Specialist to join our team. This role will be responsible for conducting site management activities according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines, and GCP; including pre-study visits, site initiation, process monitoring, routine monitoring, and close-out visits.
In this role, you will prepare and implement project plans related to clinical monitoring responsibilities and ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
You will also safeguard data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
The successful candidate will confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
Key Responsibilities:
- Conduct site management activities according to Fortrea's SOPs, ICH guidelines, and GCP.
- Prepare and implement project plans related to clinical monitoring responsibilities.
- Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to.
- Safeguard data integrity through careful source document review and verification.
- Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.
Requirements:
- Degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Minimum 5 years of experience in clinical research, preferably in a CRO environment.
- Strong knowledge of ICH guidelines, GCP, and relevant regulations.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
Benefits:
- A competitive salary ranging from $85,000 to $115,000 per year, depending on experience.
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
- Opportunities for professional growth and development.
Others:
Fortrea is an equal opportunities employer and welcomes applications from diverse candidates. We are committed to creating an inclusive workplace where everyone feels valued and respected.
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