Job Overview:

• The In-House Clinical Research Associate (IHCRA I) 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 I 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 I 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 SOP, 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 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 perform Case Report Form review, query generation and resolution against established data review guidelines, once successful completion of sign off, on Fortrea or client data management systems, as assigned by management.
• To assist with the coordination of study visits and shipment of drug, ancillary supplies, and laboratory kits/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 liaise with Study Start-up and assume maintenance activities after Site Activation. Maintenance responsibilities including but not limited to revision of FDA form 1572 or equivalent, medical license expiration, CV (if applicable), Laboratory Certificate expiration, Protocol Signature Page collection, Investigators Brochure acknowledgement of receipt, Institutional Review Board submission/Approval for Annual Renewals and PI Changes.
• To proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.
• 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 or 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 the supervision and guidance of the Clinical Team Leader (CTL) and Project Manager.
• To assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region.
ON-SITE:
• Assist Clinical Research Associate MEA I, (CRA MEA I), In-house Clinical Research Associate II (IHCRA II), Sr. In-House Clinical Research Associate (Sr. IHCRA), Clinical Research Associate 1 (CRA1), 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, Site Regulatory File, and drug accountability).
REMOTE:
• Perform remote visits (i.e., Phone PSVs, Phone SIVs, remote RMVs, remote COVs) as required by the monitoring plan.
• To facilitate translation and back translation of all necessary documents as appropriate for local country requirements and 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 as assigned.
• To attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• In lieu of the above requirement, candidates with 2-3 or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered.

Experience (Minimum Required):

• At least one year of experience in a related field, (e.g., medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing). One year of clinical research is preferred.
• An equivalent combination of education and experience to successfully perform key responsibilities. Basic understanding of biology and biological processes.
• Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP.
• Good organizational and time management skills.
• Good communication skills, oral and written.
• Exhibit general computer literacy.
• Works efficiently and effectively in a matrix environment.
• Fluent in local official language and in English, both written and verbal.

Physical Demands/Work Environment:

• General office environment.
• Some travel required.

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