CRAs & Sr. CRAs - Oncology or CAR T

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

Job summary

Confidential is seeking Experienced Oncology CRAs to lead and support our Full Service Outsourcing team, working with multiple sponsors. 1+ year of independent CRO monitoring is required. CAR-T is a plus.

Open to major hub locations across the US with 60-70% travel and 8-10 DOS per month. You will perform site monitoring, data review, SAE reporting, and coordination with vendors. A university degree or allied health certification is required.

Qualifications

• 1+ years of CRO monitoring experience.
• Oncology monitoring experience is desired.
• Bachelor's degree or allied health certification.

Responsibilities

• Monitor study sites: routine monitoring, close-out visits, and file maintenance.
• Oversee SAE reporting, data queries, and reconciliation.
• Coordinate with vendors and act as local project/contact support as assigned.

Skills

Clinical monitoring

Oncology experience

SAE reporting

Team coordination

Feasibility studies

Education

Bachelor's degree or allied health certification

Job description

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 :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 plansGeneral On-Site MonitoringEnsure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure 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 dataResponsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requestedComplete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of

SAEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by managementAssist with training of new employees, eg. co-monitoringCoordinate designated clinical projects as a Local Project Coordinator (with supervision, ifapplicable) and may act as a local client contact as assignedPerform 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 experienceOncology experience is desiredOpen 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

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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