As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Senior Clinical Research Associate - Oncology focused
Our Functional Service Provider (FSP) Team is currently seeking a remote based Oncology Experience Sr. Clinical Research Associate to support one of our top sponsors.
Minimum Qualifications
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure), an equivalent amount of experience can be substituted as appropriate.
- Previous and recent oncology experience, as an onsite traveling CRA, is required.
- In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered.
- Thorough knowledge of regulatory requirements. Thorough understanding of the drug development process. Fluent in local office language and in English, both written and verbal.
- Three-Four (3-4) years of Clinical Monitoring experience.
- Advanced site monitoring skills.
- Good computer skills with good working knowledge of a range of computer packages.
- Advanced verbal and written communication skills.
- Ability to train and supervise junior staff.
- Ability to resolve project-related problems and prioritize workload for self and team.
- Works efficiently and effectively in a matrix environment.
Responsibilities
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
- Monitor data for missing or implausible data.
- Ensure audit readiness at the site level.
- Travel, including air travel, may be required and is an essential function of the job.
- Prepare accurate and timely trip reports.
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.
- Participate in the development of protocols and Case Report Forms as assigned.
- Participate in writing clinical trial reports as assigned.
- Interact with internal work groups to evaluate needs, resources and timelines.
- Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
- Perform other duties as needed or assigned.
Travel Requirement: Yes
Compensation and Benefits
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:
- Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
- 401(K)
- Paid time off - flex package
- Employee recognition awards
- Tuition Reimbursement
Target Pay Range: $120,000 to $135,000
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We encourage all to apply.
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