Sr. CRA, FSP - Surgical / Medical Device - Central region

Fortrea•Durham, MI

1d•$130,000 - $133,000

About The Position

Fortrea is seeking experienced Central-based Senior CRAs for its FSP team, with at least one year of device experience and three or more years of clinical monitoring experience. The Senior CRA II is responsible for clinical study site monitoring and site management in accordance with Fortrea and/or sponsor standard operating procedures, project plans, and regulatory guidelines. The role may include implementing project plans, leading projects of limited scope, assuming line management responsibilities, and serving as a Local Project Coordinator or Lead CRA when assigned. The position covers routine site monitoring, closeout, pre-study and initiation visits, study-file maintenance, vendor liaison, and other assigned site-management activities. It includes protecting study participants, verifying informed-consent and protocol compliance, reviewing source documents and study data, maintaining audit readiness, preparing timely trip reports, and managing monitoring activities and travel efficiently. The role may also involve leading monitoring activities, supporting project plans and reports, coordinating vendors and supplies, conducting feasibility and quality-control work, supporting investigator recruitment and regulatory submissions, negotiating study budgets, handling SAE follow-up, reviewing CRFs and resolving queries, and training or mentoring staff. The work is performed in an office environment and may be home-based. Occasional travel to site locations, including domestic and international travel, is required; travel may involve 60–80% overnight stays. Varied hours may be required. The listed target pay range is $130,000–$133,000.

Requirements

Three years of clinical monitoring experience.
At least one year of device experience, as stated in the posting introduction.
University or college degree, preferably in a life-science field; alternatively, certification in a related allied health profession from an appropriately accredited institution, nursing certification, or medical or laboratory technology. Relevant equivalent experience may be considered in lieu of education requirements.
Thorough knowledge of regulatory requirements, including a basic understanding of requirements in other countries.
Thorough understanding of the drug-development process.
Fluency in the local office language and English, both written and verbal.
Full understanding of SAE reporting, report and narrative production, and SAE follow-up.
Advanced site-monitoring, study-site-management, and registry-administration skills.
Ability to work with minimal supervision.
Good planning and organization skills.
Good computer skills and working knowledge of a range of computer packages.
Advanced verbal and written communication skills.
Ability to train and supervise junior staff.
Ability to resolve project-related problems and prioritize workload for self and team.
Ability to work within a project team and effectively in a matrix environment.
Valid driver's license.
Ability to travel, including overnight travel; the posting specifies 60–80% overnight travel.
Ability to remain stationary frequently for 6–8 hours per day; perform repetitive hand movements; occasionally crouch or stoop and frequently bend or twist the upper body and neck; use varied computer software; and lift or carry light-to-moderate objects such as luggage and a laptop, with a maximum stated weight of 15–20 pounds.
Regular and consistent attendance.

Responsibilities

Conduct all aspects of study-site monitoring, including routine monitoring, site closeout, pre-study visits, and initiation visits.
Maintain study files, liaise with vendors, and perform site-management activities prescribed in project plans.
Ensure study staff have appropriate materials and instructions to safely enroll patients.
Verify informed-consent procedures and protocol requirements to protect study participants and comply with applicable regulations.
Review source documents and CRFs or other data-collection tools to ensure data integrity; monitor for missing or implausible data.
Perform monitoring tasks efficiently in accordance with SOPs and guidelines, manage travel expenses according to Fortrea policy, and maintain site-level audit readiness.
Prepare accurate and timely trip reports.
Manage small projects under a Project Manager or Director, as assigned.
Serve as lead monitor for a protocol or project and assist with monitoring plans and trip-report review, as assigned.
Review project progress and initiate actions to meet objectives.
Organize and deliver presentations at Investigator Meetings.
Participate in protocol and CRF development and clinical-trial report writing, as assigned.
Work with internal groups to evaluate needs, resources, and timelines.
Act as a contact for clinical-trial supplies and other vendors, as assigned.
Manage registries according to project plans and undertake feasibility work when requested.
Conduct, report, and follow up on quality-control visits when requested.
Recruit potential investigators; prepare ethics committee submissions and regulatory notifications; support document translation and meeting organization, as assigned.
Negotiate study budgets with potential investigators and assist Fortrea Legal with statements of agreement, as assigned.
Track and follow up on SAE reporting, including report and narrative production.
Independently review CRFs and generate and resolve queries using established data-review guidelines and applicable data-management systems, as assigned.
Train, mentor, and develop new employees, including through co-monitoring.
Coordinate designated clinical projects as a Local Project Coordinator and serve as a local client contact, as assigned.
Perform other duties as assigned or needed.
Travel to site locations, with 60–80% overnight travel indicated.