FSP Sr CRA I - West Coast - Oncology

Fortrea; Durham (NC); On-site; USD 115,000 - 120,000; Full time

Job summary

A leading company in clinical trials is seeking an experienced Senior Clinical Research Associate to lead the FSP team, particularly for oncology-related studies. This role demands a minimum of 3 years of clinical monitoring experience, with responsibilities including site management and ensuring compliance with protocols. Ideal candidates thrive in fast-paced, technology-driven environments and possess strong teamwork skills. Comprehensive benefits are available for eligible employees.

Benefits

Medical, Dental, Vision, Life, STD/LTD

401(K)

Paid time off (PTO) - Flex Plan

Employee recognition awards

Multiple ERG's (employee resource groups)

Qualifications

• 3+ years of Clinical Monitoring experience is required.
• Oncology experience necessary.
• Comfortable in a fast-paced environment with changing priorities.

Responsibilities

• Monitor study sites and ensure protocol adherence.
• Responsible for Serious Adverse Event (SAE) reporting and documentation.
• Assist with training of new employees and coordination of clinical projects.

Skills

Clinical Monitoring

Oncology

Teamwork

Adaptability

Technology Proficiency

Education

University or college degree or certification in a related allied health profession

Job description

We are currently seeking Experienced Sr. CRAs with over 3 years of monitoring, to lead and support our FSP team! We are open to experienced CRAs on the West Coast. Oncology experience required.

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 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, eg. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, ifapplicable) 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)
• 3+ years of Clinical Monitoring experience
• Oncology required
• Open to major hub locations on the West Coast ( CA, NV, AZ, ID, NM, OR, WA)

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 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.

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off (PTO) - Flex Plan
• Employee recognition awards
• Multiple ERG's (employee resource groups)
• Target Pay Range (based on title): $115-120K

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.