Job Overview:
The In-House Clinical Research Associate II (IHCRA II) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the IHCRA II shall reflect their experience, and level of contribution which they can make to the project. The work will involve Clinical Operations activities which will be conducted in an office or home-based setting for designated projects as well as some travel to conduct site visits or to attend client or internal team meetings as needed. The IHCRA II will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members. Activities will be conducted in compliance with Company or Sponsor SOPs, regulatory standards, and applicable guidelines. In this position candidates complete the Fortrea Monitoring Excellence Academy (MEA) training program.
Summary of Responsibilities:
- To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
- To monitor site performance and implement action plans for sites not meeting expectations in conjunction with the CRA.
- To collaborate with project team and study sites during recruitment phase, tracking, patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and CTL.
- To assist CRAs with preparation for site visits (i.e., running reports, QC of files (checking for missing documents), resolving action items from previous visits).
- To provide oversight and management of maintenance activities; to ensure compliance with renewals, document and update according to applicable local regulatory, and IRB/IEC requirements.
- To perform Case Report Form review, query generation and resolution against established data review guidelines, with or without direct supervision, on Fortrea or client data management systems, as assigned by management.
- Might be requested to work in a client facing environment as assigned.
- General On-Site Monitoring Responsibilities per the monitoring plan to include those indicated in the chart below.
- ONSITE:
- Assist Sr. In-House Clinical Research Associate (Sr. IHCRA), Clinical Research Associate 1 (CRA1) with 1+ years of independent monitoring experience, Clinical Research Associate with on-site tasks as required and according to training goals (e.g., review of Case Report Forms, SDR/SDV, Site Regulatory File and drug accountability). On-site activities can be conducted by Monitoring or solo monitoring visits once completion of successful evaluation/sign-off visit.
- REMOTE:
- Perform remote visits (i.e., Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan including remote monitoring that requires SDV/SDR after successful completion of the MEA SDR/SDV training.
- To provide oversight and management of maintenance activities; to ensure compliance with renewals, document and update according to applicable local regulatory and IRB/IEC requirement.
- To liaise with local or central laboratories in order to ensure adherence to the protocol, ensuring that all relevant documentation is current e.g., accreditation certificates, normal ranges, etc.
- To provide site training as needed via phone or teleconference/web meeting.
- To conduct IVRS/IWRS review and reconciliation, ensuring that data is accurate and up to date.
- To liaise with sponsor/medical monitor regarding clinical questions and study status.
- To assist with the coordination of study visits and shipment of drug and laboratory samples.
- To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
- To liaise with the project team and others to distribute and track clinical trial supplies, e.g., Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
- To demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections; to enter weekly details in CTMS as per study requirement.
- To liaise with the CTA to assist the project team in the production of status reports.
- To work in a timely manner in accordance with all the activities specified in the agreed study budget, under minimal supervision and guidance of the Clinical Team Leader (CTL) and Project Manager.
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities, as applicable in region.
- To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements, as needed regionally.
- To undertake other project related administrative tasks (i.e., recruitment tracking, site document preparation) as appropriate, as assigned by the Project Manager and CTL; might be requested to work in a client facing environment.
- To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
- Ensure compliance with Fortrea SOPs, and local regulatory authority regulations for clinical conduct in all aspects of daily work.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- University or college degree (biological or life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
- In lieu of the above requirement, candidates with 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries maybe considered.
- Basic understanding of ICH-GCP guidelines.
- Basic understanding of the clinical trial process.
Experience (Minimum Required):
- A minimum of 2 years of industry experience in a related role (e.g., site management, in- house CRA, study coordinator, research nurse, site pharmacist etc.).
- 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 communication skills, oral and written.
- Exhibit general computer literacy.
- Works efficiently and effectively in a matrix environment.
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: $65-72K
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