Clinical Operations Intern

**Job Overview**:
We are excited to offer a **24-week**, full time (40 hours per week) hybrid mode **In-House Internship** opportunity in Chile for individuals interested in gaining hands-on experience within our Clinical Operations Department. As an intern, you will work closely with our Clinical Operations Team to support clinical trial processes and contribute to Fortrea's mission of advancing healthcare innovation.

**Summary of Responsibilities**:
**All tasks will be performed under the close supervision of the Senior Inhouse CRA, CRAs, and the Line Manager.**
- 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 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 assist with the coordination of study visits and shipment of drug, ancillary supplies, and laboratory kits/samples.
- 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 assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region.
- To assist with TMF activities: site regulatory documents collection at site to be audit ready.
- 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

**Qualifications (Minimum Required)**:

- University degree life science or health profession from an appropriately accredited institution of Chile.
- Preferred Clinical Trials Certificate (1 year program)
- Ability to co-monitoring 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.

**Experience (Minimum Required)**:

- No clinical experience required

**Physical Demands / Work Environment**:

- General office environment.
- Some travel will be required.

Learn more about our EEO & Accommodations request here.