In House Clinical Research Associate II - FSP

Fortrea • Durham, CA

1d • $65,000 - $72,000

About The Position

The In-House Clinical Research Associate II (IHCRA II) is a member of a Clinical Project Team responsible for executing clinical research projects and supporting study team members. The role helps ensure data quality and integrity and is conducted in compliance with company or sponsor SOPs, regulatory standards, and applicable guidelines. Work takes place in an office or home-based setting for designated projects, with travel as needed for site visits and client or internal team meetings. Candidates complete Fortrea’s Monitoring Excellence Academy (MEA) training program.

The IHCRA II supports investigative sites and project teams through site contacts, monitoring and recruitment activities, site maintenance, data review, regulatory documentation, and coordination of clinical supplies and study visits. Depending on training and assignment, the role includes on-site and remote monitoring activities, including SDR/SDV after successful completion of the relevant MEA training. Work is performed under minimal supervision and guidance from the Clinical Team Leader (CTL) and Project Manager.

Requirements

• University or college degree, preferably in biological or life sciences, or certification in a related allied health profession from an appropriately accredited institution, such as nursing licensure or medical or laboratory technology.
• Candidates without the specified degree or certification may be considered with at least 2 years of relevant clinical research experience in pharmaceutical or CRO industries.
• Basic understanding of ICH-GCP guidelines and the clinical trial process.
• At least 2 years of industry experience in a related role, such as site management, in-house CRA, study coordinator, research nurse, or site pharmacist.
• Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines, and GCP.
• Ability to work within a project team and efficiently in a matrix environment.
• Good planning, organization, time management, problem-solving, and oral and written communication skills.
• General computer literacy.
• Ability to sit for extended periods and operate a vehicle safely.
• Ability to make fast, simple, repeated movements with the fingers, hands, and wrists.
• Ability to occasionally crouch and stoop, and frequently bend and twist the upper body and neck.
• Ability to access and use a variety of in-house and off-the-shelf computer software.
• Ability to lift and carry light to moderate objects, including luggage and a laptop, up to 15–20 lbs.
• Regular and consistent attendance.

Responsibilities

• Serve as a contact for project teams and investigative sites; conduct and document site contacts as required, including contact reports for telephone sessions.
• Monitor site performance and work with the CRA to implement action plans for sites that are not meeting expectations.
• Collaborate with project teams and study sites during recruitment, track patient recruitment, contact investigators as specified, and discuss study risks and opportunities with the Project Manager and CTL.
• Assist CRAs with site visit preparation, including running reports, checking files for missing documents, and resolving action items from previous visits.
• Oversee site maintenance activities and ensure renewals and documents are maintained and updated in accordance with local regulatory and IRB/IEC requirements.
• Review Case Report Forms and generate and resolve queries using Fortrea or client data management systems, as assigned.
• Perform on-site monitoring tasks according to training goals, which may include Case Report Form review, SDR/SDV, Site Regulatory File review, and drug accountability.
• Perform remote visits required by the monitoring plan, including phone PSVs and SIVs and remote RMVs and COVs; conduct remote monitoring involving SDV/SDR after successful completion of MEA training.
• Liaise with local or central laboratories to support protocol adherence and ensure relevant documentation, such as accreditation certificates and normal ranges, is current.
• Provide site training by phone or teleconference/web meeting as needed.
• Conduct IVRS/IWRS review and reconciliation to ensure data is accurate and up to date.
• Liaise with the sponsor or medical monitor regarding clinical questions and study status.
• Assist with coordinating study visits and shipment of drug and laboratory samples.
• Manage sites to help ensure subjects comply with protocol requirements, study visits, and timelines.
• Coordinate distribution and tracking of clinical trial supplies, including Case Report Forms, study medication, and laboratory kits, and ensure sites have sufficient supplies for recruitment.
• Use CTMS and enter weekly details as required by the study.
• Liaise with the CTA to assist the project team in producing status reports.
• Complete work on time and in accordance with activities specified in the agreed study budget.
• Assist with submissions and notifications to Ethics Committees and Regulatory Authorities, as applicable in the region.
• Facilitate translation and back translation of necessary documents according to local country requirements, as needed regionally.
• Undertake other project-related administrative tasks, such as recruitment tracking and site document preparation, as assigned by the Project Manager and CTL.
• Attend and present at meetings as needed, including investigator, sponsor, kick-off, and face-to-face meetings.
• Ensure daily work complies with Fortrea SOPs and local regulatory authority regulations for clinical conduct.
• Perform other duties as needed or assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level