Clinical Trial Coordinator

This is a fully remote position, open to applicants in Peru.

📋 Description

• Coordinate, manage, and finalize assigned trial activities in accordance with the task matrix.

• Conduct reviews of department, internal, country, and investigator files, documenting findings.

• Ensure that assigned tasks are completed punctually, within budget, and meet high-quality standards.

• Provide assistance for Activate, eTMF, and other clinical trial systems; keep databases up to date.

• Process documents for the Client (e)TMF, perform (e)TMF reviews, distribute communications, and generate reports.

• Analyze and reconcile study metrics and findings reports; aid in addressing site-documentation issues.

• Coordinate materials for the Investigator Site File and Pharmacy binder, as well as non-clinical study supplies.

• Support the creation of study-specific translation materials and oversee translation quality control.

• Stay informed about SOPs, client directives, and relevant regulatory guidelines.

• Conduct on-site feasibility visits as necessary in the Asia Pacific region.

• Assist in scheduling client/internal meetings and tracking local regulatory documentation.

• Support RBM activities, study-specific documentation, training needs, system access, and activity plans.

• Transmit documents to the client and centralized IRB/IEC.

• Maintain vendor trackers and assist with regulatory submissions.

• Work directly with sites to gather site-selection documents.

• Prepare regulatory compliance review packages in collaboration with the project team.

• Coordinate with internal departments to align site start-up activities with the activation critical path.

• Complete Site Interest Plans in CTMS and collect related documents when applicable.

• Document communications, follow-ups, and survey responses in real time.

• Review survey data for logical coherence, completeness, and relevance.

• Collaborate with team members and clinical personnel regarding deadlines, site challenges, and potential risks.

• Maintain plans for site contact and follow-ups; escalate concerns and issues of non-compliance.

• Provide local expertise on site capacity and experience, and recommend additional sites as needed.

• Coordinate with Global Investigator Services to address investigator queries and maintain account/contact information.

• Contribute to global strategic feasibility processes and the development of best practices.

• Train new personnel on processes and systems.

• Utilize local knowledge to identify and cultivate new sites.

⛳️ Requirements

• High/Secondary school diploma or equivalent, along with relevant formal academic or vocational qualifications.

• Bachelor's degree is preferred.

• Prior experience that equips the candidate with the knowledge, skills, and abilities to perform the duties, comparable to 0 to 1 year.

• Equivalency through a combination of relevant education, training, and/or directly related experience may be considered.

• Ability to work independently as well as collaboratively within a team.

• Strong organizational skills and meticulous attention to detail.

• Capability to accurately and efficiently analyze project-specific data/systems.

• Strong customer focus with the flexibility to adjust workload priorities.

• Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs, and WPDs.

• Proficient English language skills and good command of the local language as necessary.

• Competence in MS Office (Word, Excel, PowerPoint).

• Ability to learn and master clinical trial database systems.

• Capability to complete the organization's clinical training program.

• Effective oral and written communication skills, along with interpersonal, negotiation, judgment, decision-making, risk management, and escalation abilities.

• Skill in accurately following project work instructions.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Potential for occasional travel.

• Training and onboarding support provided.

• Opportunity to act as a buddy and train new staff members.