Sr. CRA, FSP - Cardiac / Medical Device - West Coast

Job Overview

The Senior CRA II is responsible for site monitoring and site management. Responsibilities include clinical studies according to Fortrea and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assures the implementation of project plans, as assigned.

Summary Of Responsibilities

• Responsible for 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; and other duties, as assigned.
• Responsible for all aspects of site management as prescribed in the project plans.
• General On-Site Monitoring Responsibilities:
• 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.
• Maintain data integrity by carefully reviewing source documents for missing or implausible data.
• Efficiently manage resources of the Sponsor and Fortrea by performing required monitoring tasks according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
• Audit readiness at the site level.
• Prepare accurate and timely trip reports.
• Manage small projects under the direction of a Project Manager/Director as assigned.
• Organize and make presentations at Investigator Meetings.
• Participate in the 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 suppliers (vendors) as assigned.
• Undertake feasibility work when requested.
• Conduct, report, and follow-up on Quality Control (QC) visits when requested.
• Track and follow-up on 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, 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 a local client contact as assigned.

Qualifications (Minimum Required)

• 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 a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
• Fully fluent in local office language and in English, both written and verbal.

Experience (Minimum Required)

• Three (3) years of Clinical Monitoring experience.
• Full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs.
• 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 good 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.
• Office/Home-Based Work Environment: Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
• Frequently stationary for 6-8 hours per day.
• 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.
• Variable hours may be required.