Sr CRA or CRA 2 - Oncology - FSP - New Orleans, Louisiana ; Dallas or Houston, Texas

Role Summary

Role: Sr CRA or CRA 2 – Oncology – FSP – New Orleans, LA; Dallas or Houston, TX. We are currently seeking Experienced Oncology CRAs residing near these locations to join our FSP team. You will utilize your clinical judgement to provide a high standard of care for participants and respond to emergencies in line with clinical research standards. The position requires frequent travel to client/site locations (domestic and international) as needed.

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 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 repo11s, 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

Qualifications

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
• 3+ years of onsite Clinical Monitoring experience
• Oncology experience required
• Open to major hub locations in the Northeast US

Skills

• Ability to work in a fast-paced environment with strict adherence to the protocol and timelines
• Ability to adapt to changing priorities and manage multiple tasks
• Teamwork and strong interpersonal skills
• Proficiency with electronic data capture and technology-based data management

Education

• Degree or certification in a related allied health profession (e.g. nursing licensure)

Additional Requirements

• Work Environment: Office environment with exposure to electrical office equipment
• Travel: Frequent travel to client/site locations with occasional travel domestically and internationally
• Physical Requirements:
  • Ability to sit for extended periods and operate a vehicle safely
  • Repetitive hand movements with 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 computer software developed both in-house and off-the-shelf
  • Light to moderate lifting and carrying up to 15–20 lbs
  • Regular and consistent attendance
  • Varied hours may be required