Experienced CRA 2

Open to major hub locations within the US. 60-70% travel, 8-10 days on site (DOS) per month.

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.
• General On-Site Monitoring:
  • 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 review.
  • 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).
• 6 months–2 years of Clinical Monitoring experience.
• Open to various hub locations.
• Comfortable working in an environment that is:
  • Fast-paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even a 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: data is collected directly into an electronic environment.

Benefits

• Comprehensive benefits including:
  • Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers).
  • 401(K).
  • Paid time off (PTO) – Flex Plan.
• Employee recognition awards.
• Multiple Employee Resource Groups (ERGs).

Pay

Target pay range (based on title): $105,000–$125,000.

Work Environment

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent travel to clients/site locations with occasional domestic and international travel.

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.