Oncology - CAR-T - CRAs & Sr. CRAs - Remote US

Remote Full-time
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. 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: β€’ 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 - β€’ Responsible for all aspects of site management as prescribed in the project plans β€’ General On-Site Monitoring β€’ Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study β€’ Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements β€’ 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 data β€’ Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested β€’ Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of Γ‚ SAEs β€’ Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management β€’ Assist with training of new employees, eg. co-monitoring β€’ Coordinate designated clinical projects as a Local Project Coordinator (with supervision, ifΓ‚ applicable) and may act as a local client contact as assigned β€’ Perform other duties as assigned by management Requirements β€’ University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) β€’ 1+ years of Clinical Monitoring experience β€’ Oncology experience is desired β€’ Open to various hub locations The important thing for us is you are comfortable working in an environment that is: β€’ Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. β€’ Changing priorities constantly asking you to prioritize and adapt on the spot. β€’ Teamwork and people skills are essential for the study to run smoothly. β€’ Technology based. We collect our data directly into an electronic environment. What do you get? Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: β€’ Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) β€’ 401(K) β€’ Paid time off (PTO) Γ’β‚¬β€œ Flex Plan β€’ Employee recognition awards β€’ Multiple ERGÒ€ℒs (employee resource groups) β€’ Target Pay Range (based on title): $105-145K Work Environment: β€’ Work is performed in an office environment with exposure to electrical office equipment. β€’ Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: β€’ Ability to sit for extended periods and operate a vehicle safely. β€’ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. β€’ Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. β€’ Ability to access and use a variety of computer software developed both in-house and off-the-shelf. β€’ Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. β€’ Regular and consistent attendance. β€’ Varied hours may be required. #LI - Remote Applications will be accepted on an ongoing basis. Learn more about our .
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