Clinical Trial Coordinator II

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

📋 Description

• Coordinate, manage, and execute 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.

• Process documents sent to the client eTMF, perform eTMF reviews, distribute mass mailings, and provide documents and reports to internal team members.

• Review and track local regulatory documents.

• Analyze and reconcile study metrics and findings reports.

• Maintain vendor trackers.

• Assist in compiling and distributing Investigator Site File and Pharmacy binder materials along with non-clinical study supplies.

• Aid in the creation of study-specific translation materials and ensure translation quality control.

• Offer technical and administrative project support in collaboration with internal departments and team members.

• Keep up-to-date with SOPs, client directives, and relevant regulatory guidelines.

• Ensure accurate and current trial status information is maintained in databases.

• Develop and nurture relationships with client local affiliates as needed.

• Facilitate the inclusion of Strategic Collaboration sites.

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

• Train new personnel on processes and systems.

• Maintain study documentation, team lists, training requirements, system access, and activity plans.

• Provide system support for Activate and eTMF.

• Assist with risk-based monitoring activities.

• Transmit documents to clients and centralized IRB/IEC.

• Attend kick-off meetings and take notes as required.

• Schedule and organize client/internal meetings and prepare meeting minutes.

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

• Assist with the preparation of regulatory compliance review packages and regulatory submissions.

• Obtain site-selection documents directly from sites as necessary.

• Develop site lists and maintain contact details for investigators and site staff.

• Complete Site Interest Plans in CTMS and document site communications and survey responses.

• Review survey data for logical, complete, and relevant responses.

• Collaborate with teammates on deadlines, site issues, and risks.

• Plan and monitor site contact and follow-up, escalating concerns and instances of non-compliance.

• Serve as a local expert regarding site capacity and experience, supporting site tiering.

• Conduct phone interviews with physicians and site personnel to gather protocol-level input.

• Liaise with Global Investigator Services to resolve investigator inquiries and maintain account/contact information.

• Contribute to global strategic feasibility processes and best practices.

⛳️ Requirements

• Bachelor's degree preferred.

• A minimum of 2 years of relevant experience in a CTC role.

• Proficiency in Veeva eTMF and CTMS.

• Experience managing global clinical trials and coordinating with local/global team members.

• Vendor management experience preferred.

• Capability to work independently or as part of a team.

• Strong organizational skills and meticulous attention to detail.

• Ability to analyze project-specific data and systems.

• Strong customer focus.

• Flexibility and adaptability to evolving project timelines.

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

• Excellent English language and grammar skills, with proficient local language skills as necessary.

• Good presentation capabilities.

• Proficiency in MS Office (Word, Excel, PowerPoint) and the ability to learn clinical trial database systems.

• Ability to successfully complete the organization's clinical training program.

• Effective oral and written communication skills, including interaction with medical personnel.

• Good negotiation skills.

• Basic understanding of medical/therapeutic areas and medical terminology.

• Basic organizational and planning skills.

• Basic knowledge of local health systems.

• Working knowledge of GCP and applicable SOPs.

• Ability to operate in a matrix environment.

• Strong relationship-building skills.

• Ability to manage risk and perform appropriate risk escalation.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.