CRAs & Sr. CRAs - Radiopharmaceutical Therapies - Remote US

Confidential; Durham (NC); Remote; USD 105,000 - 145,000; Full time

Job summary

Confidential is seeking experienced CRAs with radiopharmaceutical therapeutic expertise to lead the Full Service Outsourcing team across the US. The role requires 1+ year of independent CRO/sponsor monitoring and involves 60-70% travel to various sponsor sites, with opportunities at major hub locations nationwide.

You will monitor study sites, ensure data integrity, manage SAE processes, and coordinate with vendors while supporting site staff and project goals.

Qualifications

• 1+ year of CRO/sponsor monitoring experience.
• Radiopharmaceutical experience is desired.
• Bachelor’s degree in a related field.
• Willing to travel 60–70% across the US.

Responsibilities

• Lead and support study site monitoring, including routine monitoring and close-out.
• Maintain study files and conduct site initiation and pre-study visits.
• Coordinate with vendors and clients; assist with training of new staff.
• Ensure informed consent and protocol adherence per regulatory requirements.
• Monitor data for missing or implausible entries and assist with SAE reporting.

Skills

Clinical monitoring

Radiopharmaceuticals

GCP knowledge

Emergency response

Project coordination

Education

Bachelor’s degree in life sciences

Job description

We are currently seeking Experienced CRAs with Radiopharmaceutical therapeutic expertise. To lead and support our Full Service Outsourcing team working with various sponsors. 1+ year of independent CRO/sponsor monitoring required. 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: 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 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 repos, 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, eg. 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. Radiopharmaceutical 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 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.

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: Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)401(K)Paid time off (PTO) – Flex PlanEmployee recognition awardsMultiple 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 travel both domestic and international.

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 moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required.

#LI - RemoteApplications will be accepted on an ongoing basis.

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