Oncology - CAR-T - CRAs & Sr. CRAs - Remote US
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 days of site visits per month.
What You Will Do
You will utilize your skills, knowledge, and clinical judgment 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; monitor data for missing or implausible values.
- 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: no deviations from the study protocol are allowed, and missing a deadline even by a few minutes creates a quality issue.
- Subject to changing priorities that require you to prioritize and adapt on the spot.
- Team‑oriented, with strong people skills essential for the study to run smoothly.
- Technology based, with data collected directly into an electronic environment.
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 (PTO) – Flex Plan
- Employee recognition awards
- Multiple ERG’s (employee resource groups)
- Target Pay Range (based on title): $105‑145K
Work Environment
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequent travel to clients/site locations with occasional domestic and international travel.
Physical Requirements
- Ability to sit for extended periods and operate a vehicle safely.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in‑house and off‑the‑shelf.
- Light to moderate lifting and carrying (or otherwise moving) objects including luggage and laptop computer with a maximum lift of 15‑20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
Remote. Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here. #J-18808-Ljbffr Apply tot his job Apply To this Job