FSP - Clinical Research Associate 2 - CRA 2 / Sr. CRA 1- Northeast or Central - Oncology

Fortrea•Durham, MI

19h•$100,000 - $115,000•Hybrid

About The Position

Our FSP team is currently seeking Unblinded CRAs with 1-3 years of monitoring. Candidates must reside within the United States. 8-10 days on site per month being a mix of onsite and remote. Open to West coast, Central and East Coast major hub locations. 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.

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
50-60% overnight travel
Comfortable working in an environment that is fast paced, with changing priorities, requires teamwork and people skills, and is technology based.
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.

Nice To Haves

Resided within the United States
Open to West coast, Central and East Coast major hub locations
Unblinded CRAs
3 years of monitoring experience

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 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, 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