Sub-Investigator

• 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.

• 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.

• 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.

• 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.

• 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.
• 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