Culmen International is hiring Sub-Investigators to assist with our healthcare mission in Cebu City, Philippines.
The role performs delegated study-related clinical duties, supports participant screening and follow-up, assists in protocol implementation, and helps maintain accurate clinical documentation in accordance with the study protocol, Good Clinical Practice (GCP), sponsor requirements, and applicable local regulations.
Clinical Support
- Perform delegated study-related clinical duties under the supervision of the Principal Investigator.
- Review medical history and assist in assessing participant eligibility based on protocol-defined inclusion and exclusion criteria.
- Conduct protocol-required clinical assessments, targeted physical examinations, and follow-up evaluations, as delegated.
- Support enrolment, vaccination-related clinical review, illness visits, and follow-up assessments for study participants.
- Provide clinical input to the Principal Investigator regarding participant safety, continued participation, and referral for medical care, when needed.
- Promptly escalate any clinically significant findings or participant safety concerns to the Principal Investigator.
Protocol Implementation
- Support day-to-day implementation of study procedures for CHIKPREP and CHIK V in accordance with approved protocols, manuals, and study instructions.
- Ensure that delegated procedures are performed only after informed consent or assent has been properly obtained and documented by authorized study personnel.
- Support timely conduct of scheduled and unscheduled visits, including post-vaccination follow-up and illness-related assessments.
- Attend and complete all required protocols, GCP, CITI, HIPAA, safety, systems, and study-specific trainings prior to performing delegated study duties.
Safety and Participant Follow-up
- Support the assessment, documentation, and follow-up of adverse events, serious adverse events, and other reportable safety information, as delegated by the Principal Investigator.
- Review participant symptoms, concomitant medications, and relevant clinical findings during study visits and follow-up contacts.
- Assist in ensuring that participant safety concerns are documented and communicated appropriately to the Principal Investigator and study team.
Documentation and Data Quality
- Ensure that delegated clinical findings, assessments, and relevant medical notes are accurately documented in source records and study documents.
- Review assigned clinical documentation for completeness, consistency, and alignment with protocol requirements.
- Assist in resolving clinical data queries and providing clarification on delegated assessments and documentation, as needed.
- Maintain timely and accurate records related to assigned study responsibilities.
Team Coordination and Study Support
- Work closely with study coordinators, nurses, laboratory personnel, pharmacists, and other site staff to support smooth study implementation.
- Participate in study meetings, site initiation activities, monitoring visits, and other relevant project activities, as needed.
- Support consistent implementation of assigned study procedures in coordination with the site team.
- Assist with participant follow-up and other study-related coordination activities, as needed.
- Perform other study-related tasks assigned by the Principal Investigator that are within the scope of the role.
- Prior clinical research experience is an advantage but is not required.
