Sr. CRA 2, FSP - Oncology - Central & Midwest

Fortrea; Minnesota; Hybrid; USD 115,000 - 140,000; Full time

Job summary

Fortrea is seeking a Sr. CRA 2 in Minnesota with over 4 years of Clinical Monitoring experience, specifically in Oncology. The role involves site monitoring, data integrity verification, and adherence to clinical research standards while traveling 60-70%. Successful candidates will thrive in fast-paced environments and enjoy teamwork. A university degree in a related health field is required, and the position offers a target pay range of $115 - $140K, with remote work options available.

Qualifications

• 4+ years of Clinical Monitoring experience needed.
• Oncology experience is required.
• Certification in a related allied health profession preferred.

Responsibilities

• Conduct monitoring and close-out of clinical sites.
• Ensure adherence to informed consent procedures.
• Assist with training of new employees.

Skills

Clinical Monitoring

Oncology monitoring

Teamwork

Adaptability

Data Management

Education

University or college degree in a related field

Job description

Our FSP team is currently seeking a Sr. CRA 2 with 4+ years of monitoring as well as strong Oncology monitoring experience residing in the Central and Mid-West US.

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
• 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 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)
• 4+ years of Clinical Monitoring experience
• Oncology experience is required
• 60-70% overnight travel

The important thing for us is you are 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. We collect our data directly into an electronic environment.

Work 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.
• Target Pay Range: $115 - $140K

Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.