Clinical Trial Coordinator

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

📋 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 timely, within budget, and meet high-quality standards.

• Communicate project risks to project leads and the line manager.

• Maintain study documentation, team lists, training trackers, system access, activity plans, and eTMF records.

• Provide support for GoBalto and eTMF systems.

• Assist with risk-based monitoring activities.

• Process documents, conduct eTMF reviews, manage mass mailings, and generate reports for internal team members.

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

• Review and track local regulatory documents.

• Transmit documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Assist in clarifying and resolving site documentation findings.

• Maintain vendor trackers.

• Support Investigator Site File and Pharmacy binder materials and study supplies.

• Assist with translation materials and ensure translation quality control.

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

• Act as a cross-functional liaison and potentially serve as a study lead.

• Provide support for onboarding as a buddy and train new staff.

• Contribute to departmental and cross-functional process improvement initiatives.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• A minimum of 4 years of relevant experience.

• Ability to work both independently and as part of a team.

• Strong organizational skills with a keen attention to detail.

• Capable of managing multiple tasks efficiently and effectively.

• Proficient in analyzing project-specific data and systems.

• Strong customer service orientation.

• Flexibility and adaptability to changing project timelines.

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

• Excellent command of the English language and grammar.

• Proficiency in local language skills as required.

• Strong presentation skills.

• Proficient in MS Office applications, including Word, Excel, and PowerPoint.

• Ability to learn and master clinical trial database systems.

• Capability to successfully complete the PPD clinical training program.

• Self-motivated with a positive attitude and strong interpersonal skills.

• Willingness to occasionally drive to site locations and travel as needed.

🏝️ Benefits

• Fully remote work arrangement.

• Potential for occasional travel.

• Accessibility/disability accommodations provided during the application and interview process.

• Comprehensive benefits and privileges of employment, with reasonable accommodations as needed.