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

Fortrea•Durham, NC

About The Position

Fortrea’s FSP team is seeking an experienced, Central-region-based Senior CRA with at least one year of device experience and at least three years of clinical monitoring experience. The Senior CRA is responsible for clinical site monitoring and management in accordance with Fortrea and/or sponsor standard operating procedures and regulatory guidelines. The role supports implementation of project plans, may lead projects of limited scope, and may assume line-management, Local Project Coordinator, or Lead CRA responsibilities as assigned. Responsibilities include routine site monitoring and closeout, maintaining study files, conducting pre-study and initiation visits, managing sites and registries, and liaising with vendors. The Senior CRA protects study participants, verifies informed-consent and protocol compliance, reviews source documents and study data, maintains site audit readiness, and prepares timely trip reports. The role may also support project planning, investigator meetings, protocol and Case Report Form development, clinical trial reports, feasibility work, quality-control visits, regulatory and ethics submissions, investigator recruitment and budget negotiations, safety-event reporting, data review, and the training and mentoring of colleagues. The position involves 60–80% overnight travel, potentially including domestic and international travel. Work is performed in an office or home-based environment, with occasional drives to sites. Varied hours may be required. The stated target pay range is $130,000–$133,000.

Requirements

At least three years of clinical monitoring experience.
At least one year of device experience.
University or college degree, preferably in life sciences; alternatively, certification in a related allied health profession from an appropriately accredited institution, nursing certification, or medical or laboratory technology qualification. Fortrea may consider relevant equivalent experience in lieu of educational 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 Serious Adverse Event reporting, report production, narratives, and follow-up.
Advanced site-monitoring, study-site-management, and registry-administration skills.
Ability to work with minimal supervision.
Good planning, organization, and computer skills, including 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 60–80% overnight, with occasional domestic and international travel.
Regular and consistent attendance; varied hours may be required.
Ability to remain stationary frequently for 6–8 hours per day; perform repetitive hand and finger movements; occasionally crouch or stoop; frequently bend and twist the upper body and neck; and lift or carry objects, including luggage and a laptop, weighing up to 15–20 pounds.

Nice To Haves

Life-science degree.

Responsibilities

Conduct all aspects of study-site monitoring, including routine monitoring, site closeout, study-file maintenance, and pre-study and initiation visits.
Manage study sites and registries in accordance with project plans.
Ensure study staff have the materials and instructions needed to conduct the protocol safely.
Protect study participants by verifying informed-consent procedures and protocol compliance with applicable regulatory requirements.
Review source documents and data collection tools to ensure data integrity, and monitor for missing or implausible data.
Perform required monitoring tasks efficiently in accordance with SOPs and guidelines, and manage travel expenses economically under Fortrea policy.
Maintain site-level audit readiness and prepare accurate, timely trip reports.
Manage small projects under a Project Manager or Director, and serve as lead monitor for a protocol or project when assigned.
Assist with monitoring plans and trip-report review, review project progress, and initiate actions to meet objectives.
Organize and present at Investigator Meetings.
Participate in protocol, Case Report Form, and clinical trial report development as assigned.
Coordinate with internal work groups to evaluate needs, resources, and timelines.
Act as a contact for clinical trial supplies and other vendors as assigned.
Undertake feasibility work and conduct, report, and follow up on Quality Control visits when requested.
Recruit potential investigators; prepare ethics committee submissions and regulatory notifications; and coordinate study-document translation and meetings as assigned.
Negotiate study budgets with potential investigators and assist Fortrea’s legal department with statements of agreement as assigned.
Track and follow up on Serious Adverse Event reporting, and process reports and narratives.
Independently review Case Report Forms and generate and resolve queries using Fortrea or client data-management systems, as assigned.
Assist with training, mentoring, and developing new employees, including co-monitoring.
Coordinate designated clinical projects as a Local Project Coordinator and serve as a local client contact when assigned.
Perform other duties as assigned or needed.