Job Description

The Clinical Research Associate I MEA (CRA I MEA) 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 CRA I MEA 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 CRA I MEA 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.

of Responsibilities:

• To provide clinical support for projects according to Fortrea Standard Operating Procedures, ICH Guidelines and GCP.
• To develop and/or maintain tracking systems for clinical projects.
• To assist teams and conducts site monitoring of clinical research studies according to Fortrea Standard Operating Procedures, ICH Guidelines and GCP.
• Site management responsibility for clinical studies according to Fortrea Standard Operating Procedures, ICH Guidelines and GCP.
• Responsible for all aspects of study site monitoring with or without direct supervision (as per the training status of the CRA I MEA). This includes remote and/or onsite conduct of pre-study visits, site initiation visits, routine monitoring visits and close-out visits of clinical sites.
• Conduct site management activities, maintain study files, liaise with vendors; perform other duties, as assigned.
• Responsible for aspects of registry management as prescribed in the project plans.
• 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 2 (CRA 2), Senior Clinical Research Associate 1 (Sr. CRA 1) and Senior Clinical Research Associate 2 (Sr. CRA 2) 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). All activity to be conducted under direct supervision of the primary monitor, until Evaluation Sign-Off visit is successfully completed for the CRA I MEA.
• 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 SDR/SDV after successful completion of the MEA training program.
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. o Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. o Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. o Monitor data for missing or implausible data.
• Initiate, monitor and close out clinical investigative sites, with or without direct supervision from CRA 1, CRA 2, Sr. CRA 1 and 2, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition. Until Evaluation Sign-Off visit is successfully completed, the CRA I MEA should be accompanied by an experienced lead or co-monitor (as per training status and agreement from Line Management). o Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy, including air travel, may be required as per essential job functions.
• Prepare accurate and timely trip reports.
• Perform CRF 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.
• Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management.
• Provide coverage for clinical contact telephone lines, as required.
• Update, track and maintain study-specific trial management tools/systems.
• Generate and track drug shipments and supplies, as needed.
• Track and follow-up on serious adverse events as assigned.
• Implement study-specific communication plan as assigned.
• Attend face-to-face meetings or remote meetings/teleconferences as needed (Investigators’ meetings, project team meetings, Sponsor meetings, Kick-off meetings etc.) and present certain topics, as assigned.

Qualifications (Minimum Required):

• University or college degree (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 may be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Basic understanding of ICH Guidelines and GCP including basic understanding of regulatory requirements
• Basic understanding of the clinical trial process
• Valid Driver’s License.

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, organizational, time management and problem-solving abilities.
• Good communication skills, oral and written.
• Exhibit general computer literacy.
• Works efficiently and effectively in a matrix environment
• Fluent in local office language and in English, both written and verbal

Preferred Qualifications Include:

• One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical laboratory, research, data analysis, data management or technical writing) is preferred.
• Working knowledge of Fortrea SOPs for site monitoring.

Physical Demands/Work Environment:

• Travel requirements: 60-80%, overnight stays 60-80%.

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