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 by performing required monitoring tasks in accordance with 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.
• 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.
• Undertake feasibility work when requested.
• Conduct, report, and follow-up on Quality Control (QC) visits when requested.
• Recruit potential investigators, prepare EC submissions, notifications to regulatory authorities, translate study-related documentation, organize meetings and other tasks as instructed by supervisor as assigned.
• 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.
• Absorb and apply advanced site monitoring, study site management, and registry administration skills.
• Work independently with minimal supervision, demonstrating good planning and organization skills.
• Use advanced verbal and written communication skills to interact with various stakeholders.
• Resolve project-related problems and prioritize workload for self and team.
• Work efficiently and effectively in a matrix environment.
• Perform light to moderate lifting and carrying (or otherwise move) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance with varied hours may be required.

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.
• Fluent in local office language and in English, both written and verbal.
• Valid Driver's License.