Job Title: Clinical Trial Associate
Location: Hyderabad, India (Remote)
Job Type: Contract to Hire
Essential Responsibilities:
- Support the Clinical Operations team under the supervision of the Clinical Program Manager.
- Contact clinical trial sites, vendors, CROs, and partners as needed.
- Perform administrative tasks to support clinical project teams.
- Maintain the Trial Master File (TMF) by submitting applicable documents and ensuring completeness.
- Prepare meeting agendas, take meeting minutes, and maintain tracking logs.
- Track clinical trial progress, including enrollment tracking and status update reports.
- Follow applicable Standard Operating Procedures (SOPs).
- Assist with the creation and maintenance of documentation for assigned clinical trials (e.g., presentations, pharmacy manuals, regulatory binders, lab manuals, and training materials).
- Partner with external vendors to ensure accurate distribution of clinical trial-related materials to sites and team members.
- Schedule internal meetings and external collaborator meetings; generate timely meeting minutes.
- Assist in the creation and distribution of study-level communications to stakeholders.
Additional Responsibilities:
- Support the study team by proactively identifying, resolving, and escalating issues to assigned staff.
- Under general supervision, collect, process, and track investigator site and regulatory documents required by the FDA and other regulatory authorities.
- Coordinate, process, and track shipments (e.g., supplies, study-related materials).
- Serve as the point of contact for clinical supplies and close-out documentation.
- Prepare and maintain essential study documents such as clinical study files, regulatory binders, and operations manuals (e.g., informed consent forms, protocols, investigator brochures).
- Assist with the quality review of documentation, including ICFs and regulatory green light packages.
- Manage additional tasks with minimal supervision.
Skills and Experience:
- Bachelor’s degree (B.Pharmacy or Pharm D or BDS) in biological sciences; advanced degree preferred.
- Minimum of 2+ years of relevant industry experience.
- Demonstrated knowledge of FDA, ICH, and GCP regulations and guidelines.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Excellent written and verbal communication skills.
- Strong attention to detail, time management, and organizational skills.
- Ability to multi-task, prioritize, and handle time-sensitive demands and unexpected events.
- Ability to establish and maintain effective working relationships with coworkers, managers, vendors, and clients.
- Comfortable working in a fast-paced small company environment and adaptable to changing priorities.