FSP Clinical Research Associate 2 - West Coast & Central

About the role

Our FSP team is currently seeking a CRA 2 on the West Coast or Central with 2 years of monitoring. 8-10 days on site per month being a mix of onsite and remote.

What You Will Do

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Responsibilities

• Responsible for all aspects of study site monitoring including routine monitoring and close-out 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
• 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
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document
• Monitor data for missing or implausible data
• Responsible for all aspects of registry management as prescribed in the project plans
• Undertake feasibility work when requested
• Complete 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 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
• Perform other duties as assigned by management

Requirements

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 2 years of Clinical Monitoring experience
• 60% overnight travel

Work Environment

• Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue
• Changing priorities constantly asking you to prioritize and adapt on the spot
• Teamwork and people skills are essential for the study to run smoothly
• Technology based. We collect our data directly into an electronic environment
• Work is performed in an office environment with exposure to electrical office equipment
• Frequent travel to clients/ site locations with occasional travel both domestic and international

Physical Requirements

• Ability to sit for extended periods and operate a vehicle safely
• 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
• Varied hours may be required

Pay

Target Pay Range: $100-112K - Remote