Culmen International is hiring a part-time
Clinical Trial 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.
- Medical degree
- Active physician license in the Philippines and in good professional standing.
- Clinical experience in family medicine, internal medicine, pediatrics, public health, infectious diseases, or related fields preferred.
- Must have affiliation with CIM/CVGH
- Basic understanding of Good Clinical Practice (GCP), informed consent, participant safety monitoring, and protocol compliance.
- Ability to perform delegated clinical assessments and provide appropriate medical input under the supervision of the Principal Investigator.
- Strong attention to detail and ability to maintain accurate and timely documentation.
- Good communication and teamwork skills, with ability to work effectively with a multidisciplinary study team.
- Willingness to support time-sensitive study activities, participant follow-up, and protocol-required assessments.
- Prior clinical research experience is an advantage but is not required.
Culmen International is committed to enhancing international safety and security, strengthening homeland defense, advancing humanitarian missions, and optimizing government operations. With experience in over 150 countries, Culmen supports our clients to accomplish critical missions in challenging environments.
To learn more about Culmen International, please visit www.culmen.com
At Culmen International, we are committed to creating and sustaining a workplace that upholds the principles of Equal Employment Opportunity (EEO). We believe in the importance of fair treatment and equal access to opportunities for all employees and applicants. Our commitment to these principles is unwavering across all our operations worldwide.
