Sr. Clinical Research Associate - Oncology or CAR T
Fortrea
Summary
We are currently seeking Experienced Oncology CRAs to lead and support our Full Service Outsourcing team working with various sponsors. 1+ year of independent CRO/sponsor monitoring required. CAR-T desired. Open to major hub locations across the US. 60-70% travel, 8-10 DOS per month.
Job description
What You Will Do
You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
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
- Responsible for all aspects of site management as prescribed in the project plans
- General On-Site Monitoring
- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
- 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
- Responsible for all aspects of registry management as prescribed in the project plans; undertake feasibility work when requested
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
- Assist with training of new employees, e.g. co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
- Perform other duties as assigned by management
Requirements
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
- 1+ years of Clinical Monitoring experience
- Oncology experience is desired
- Open to various hub locations
The important thing for us is you are comfortable working in an environment that is fast paced, with changing priorities constantly, where teamwork and people skills are essential, and technology based.
Requirements
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
- 1+ years of Clinical Monitoring experience
- Oncology experience is desired
- Open to various hub locations
- Ability to travel 60-70% of the time
Benefits
- Medical, Dental & Vision
- Life Insurance
- STD/LTD Insurance
- 401(k)
- Paid Time Off (PTO)
- Employee Recognition Awards
- Employee Resource Groups
Company overview
Fortrea Holdings Inc. is a leading global contract research organization (CRO) that provides comprehensive clinical development solutions to the pharmaceutical, biotechnology, and medical device industries. Headquartered in Durham, North Carolina with operations in over 90 countries, Fortrea specializes in managing all aspects of clinical trials from Phase I through IV, including clinical pharmacology and post-approval services. The company offers a wide range of services including regulatory affairs, protocol design, operational planning, patient recruitment, project management, data management, biostatistics, pharmacovigilance, and medical writing. With over 30 years of clinical research experience, Fortrea has evolved from its heritage as Covance and Labcorp into a pureplay CRO focused on delivering agile, fit-for-purpose solutions for both emerging and established life sciences companies. The company has conducted more than 5,850 clinical trials involving over 1 million subjects in the past five years, with particular expertise in oncology, central nervous system disorders, rare diseases, and cell and gene therapies.