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.
• Afford resources wisely by performing required monitoring tasks efficiently, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
• Ensure 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.
• Assume line management responsibilities, as assigned.
• Act in the project role of a Local Project Coordinator or Lead CRA 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.
• Have a 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.