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

About the role

The Senior CRA II is responsible for site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines. The role assures implementation of project plans, functions as leader for projects of limited scope, assumes line management responsibilities, and may act as Local Project Coordinator or Lead CRA as assigned. Position is central-based with 60–80% overnight travel required.

Responsibilities

• Perform all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors.
• Manage all aspects of site management as prescribed in project plans.
• Ensure study staff have proper materials and instructions to safely enroll patients.
• Protect study patients by verifying informed consent procedures and protocol adherence per regulatory requirements.
• Ensure data integrity on Case Report Forms (CRFs) or other data collection tools through careful source document review.
• Monitor data for missing or implausible entries.
• Manage Sponsor and Fortrea resources efficiently per SOPs and guidelines, including economical travel per Fortrea travel policy.
• Ensure audit readiness at the site level.
• Prepare accurate and timely trip reports.
• Manage small projects under direction of a Project Manager/Director as assigned.
• Serve as lead monitor for a protocol or project; assist in establishing monitoring plans and trip report review as assigned.
• Review project progress and initiate actions to achieve target objectives.
• Organize and present at Investigator Meetings.
• Participate in development of protocols and Case Report Forms as assigned.
• Participate in writing clinical trial reports as assigned.
• Interact with internal work groups to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and other vendors as assigned.
• Manage all aspects of registry management per project plans.
• Undertake feasibility work when requested.
• Conduct, report, and follow up on Quality Control (QC) visits when requested.
• Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study documentation, organize meetings, and perform other tasks as instructed by supervisor.
• Negotiate study budgets with investigators and assist Fortrea legal with statements of agreement as assigned.
• Track and follow up on Serious Adverse Event (SAE) reporting; produce reports, narratives, and follow up on SAEs.
• Independently perform CRF review, query generation, and resolution per data review guidelines on Fortrea or client data management systems as assigned.
• Assist with training, mentoring, and development of new employees (e.g., co-monitoring).
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision if applicable) and may act as local client contact as assigned.
• Perform other duties as assigned by management.

Qualifications

• University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
• Thorough knowledge of regulatory requirements including basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
• Fluent in local office language and in English, both written and verbal.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience

• Three (3) years of Clinical Monitoring experience.
• Full understanding of Serious Adverse Event (SAE) reporting, report production, narratives, and follow-up.
• Advanced site monitoring skills.
• Advanced study site management skills.
• Advanced registry administration skills.
• Ability to work with minimal supervision.
• Good planning and organization skills.
• Good computer skills with 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.
• Works efficiently and effectively in a matrix environment.
• Valid Driver's License.

Physical Demands & Work Environment

Travel requirements: 60–80% overnight. Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional domestic and international travel.

• Frequently stationary for 6–8 hours per day.
• Repetitive hand movement of both hands with ability to make fast, simple, repeated movements of 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 moving) objects including luggage and laptop computer with a maximum lift of 15–20 lbs.
• Regular and consistent attendance required.
• Varied hours may be required.

Pay

Target pay range: $130,000–$133,000 per year.

Schedule

Travel required 60–80% overnight; varied hours may be required.