FSP In-House CRA II - Remote US
Job Title: FSP In-House CRA II - Remote US
Job Location: Durham
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Job Description
Our FSP team is currently seeking In-house CRA IIs to join our FSP team! Prior CRO experience preferred. Remote based US.
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:
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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.
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To monitor site performance and implement action plans for sites not meeting expectations in conjunction with the CRA.
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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.
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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).
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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.
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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.
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Might be requested to work in a client facing environment as assigned.
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General On-Site Monitoring Responsibilities per the monitoring plan to include those indicated in the chart below.
- ONSITE:
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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:
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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.
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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.
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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.
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To provide site training as needed via phone or teleconference/web meeting.
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To conduct IVRS/IWRS review and reconciliation, ensuring that data is accurate and up to date.
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To liais