Oncology - CAR-T - CRA II - Remote

We are currently seeking Experienced Oncology CRA 2s to lead and support our Full Service Outsourcing team. CAR‑T desired. Open to major hub locations on the East & West Coast. 60‑70% travel, 8‑10 DOS per month.

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.

• 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 monitoring 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.

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure).
• 1-3+ 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: where no deviations from the study protocol are allowed, and not meeting a timeline for even a few minutes will create a quality issue.
• Changing priorities constantly asking you to prioritize and adapt on the spot.
• Teamwork and people skills are essential for the study to run smoothly.
• Technology based. We collect our data directly into an electronic environment.

• 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): $105‑117K.

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent travel to clients/site locations with occasional travel both domestic and international.

• 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 moves) 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.