Culmen is hiring Study Nurses to work onsitein Cebu City, Philippines.
The Study Nurse supports the day-to-day implementation of the CHIKPREP and CHIK V studies at site level. The role helps ensure that study participants are properly screened, enrolled, followed up, and cared for in line with the study protocol, Good Clinical Practice (GCP), and site procedures. The Study Nurse also supports participant safety, study documentation, specimen collection, and coordination of study visits and follow-up activities.
1. Participant Care and Study Visits- Support screening, enrolment, and follow-up visits for study participants.
- Explain study visit procedures to participants in a clear and respectful manner.
- Take and record vital signs, medical history, and other basic clinical information as required by the protocol.
- Assist the investigator or sub-investigator during participant assessments and study procedures.
- Observe participants after vaccination or other study procedures, as required.
2. Study Procedures- Perform delegated nursing procedures in line with the protocol and site delegation log.
- Support blood collection, specimen handling, labeling, storage, and transfer according to study procedures.
- Assist with pregnancy testing, rapid testing, symptom review, and other protocol-required procedures as applicable.
- Help prepare clinic rooms, study supplies, and participant materials for each visit.
- Ensure all study activities are carried out only after informed consent or assent has been properly obtained.
3. Participant Follow-Up- Contact participants for scheduled follow-up visits, phone calls, and illness checks as required by the study.
- Remind participants about appointments and support visit scheduling and rescheduling.
- Help monitor participants for symptoms, adverse events, or acute febrile illness, and promptly report concerns to the investigator or sub-investigator.
- Support participant retention by maintaining good communication and a professional, caring approach.
4. Documentation and Data Support- Record study procedures and nursing activities accurately in source documents, logs, and study forms.
- Ensure documentation is complete, timely, and consistent with protocol and site requirements.
- Help maintain trackers for visits, specimen collection, and participant follow-up.
- Support preparation of documents during monitoring visits, audits, and sponsor review.
5. Coordination and Team Support- Work closely with investigators, coordinators, laboratory staff, pharmacists, and other study team members.
- Support site readiness activities, training sessions, and study meetings.
- Help manage study supplies and alert the team when items need to be replenished.
- Support outreach or surveillance-related activities, if required by the study.
6. Training and Compliance- Attend and complete all required trainings, including protocol training, Good Clinical Practice (GCP), safety reporting, and study-specific procedures, before performing assigned study duties.
- Follow the approved protocol, study manuals, site SOPs, and applicable regulatory requirements at all times.
- Maintain participant confidentiality and handle study information carefully and professionally.
- Prior experience in clinical research is an advantage but not required.
