In House Clinical Research Associate II - FSP

Fortrea•Durham, NC

About The Position

The In-House Clinical Research Associate II (IHCRA II) is an essential member of a Clinical Project Team and supports the execution of clinical research projects. Responsibilities are assigned according to experience and level of contribution. Work is conducted in an office or home-based setting for designated projects, with travel as needed for site visits and client or internal team meetings. The role supports the quality and integrity of study data and other study activities in compliance with company or sponsor SOPs, regulatory standards, and applicable guidelines. The position includes completion of Fortrea’s Monitoring Excellence Academy (MEA) training program. The IHCRA II serves as a contact for project teams and investigative sites, monitors site performance, supports recruitment, prepares for site visits, and manages site maintenance activities. The role includes case report form review, query generation and resolution, remote and on-site monitoring tasks according to the monitoring plan and training, and coordination with sponsors, laboratories, sites, and project team members. The position may involve client-facing work and attendance or presentations at study-related meetings. Work is performed under minimal supervision and guidance from the Clinical Team Leader and Project Manager, with other project-related duties assigned as needed.

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 certification.
In lieu of the degree or allied-health certification, candidates with two or more years of relevant clinical research experience in the pharmaceutical or CRO industries may be considered.
Basic understanding of ICH-GCP guidelines and the clinical trial process.
At least two 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.
Good planning, organization, time-management, and problem-solving skills.
Good oral and written communication skills.
General computer literacy.
Ability to work efficiently and effectively in a matrix environment.
Ability to sit for extended periods and operate a vehicle safely.
Ability to perform repetitive hand movements and fast, simple, repeated movements of the fingers, hands, and wrists.
Ability to crouch and stoop occasionally, and bend and twist the upper body and neck frequently.
Ability to access and use a variety of in-house and off-the-shelf computer software.
Ability to lift and carry, or otherwise move, light to moderate objects including luggage and a laptop computer, up to 15–20 lbs.
Regular and consistent attendance; varied hours may be required.

Responsibilities

Serve as a contact for project teams and investigative sites; conduct site contacts and document them, including contact reports for telephone sessions.
Monitor site performance and work with the CRA to implement action plans for sites that do not meet expectations.
Collaborate with project teams and sites during recruitment, track recruitment, contact investigators as specified, and discuss study risks and opportunities with the Project Manager and CTL.
Assist CRAs in preparing for site visits by running reports, checking files for missing documents, and resolving prior visit action items.
Oversee site maintenance activities and ensure renewals and documents are maintained and updated in line with local regulatory and IRB/IEC requirements.
Review Case Report Forms and generate and resolve queries according to established data review guidelines using Fortrea or client data management systems.
Assist with on-site monitoring tasks according to the monitoring plan and training goals, including Case Report Form review, SDR/SDV, Site Regulatory File review, and drug accountability.
Perform remote visits required by the monitoring plan, including phone PSVs, phone SIVs, remote RMVs, and remote COVs; perform remote monitoring requiring SDV/SDR after completing MEA SDR/SDV 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 support subjects’ compliance 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 according to study requirements.
Liaise with the CTA to assist the project team in producing status reports.
Complete activities in a timely manner and according to the agreed study budget, with minimal supervision and guidance from the CTL and Project Manager.
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 project-related administrative tasks, such as recruitment tracking and site document preparation, as assigned.
Attend and present at investigator, sponsor, kick-off, face-to-face, and other meetings as needed.
Ensure compliance with Fortrea SOPs and local regulatory authority regulations for clinical conduct.
Perform other duties as needed or assigned.