Responsibilities
- Delivers consultations and educational support to study participants in inpatient or outpatient settings under the supervision of the principal investigator.
- Performs physical examinations and follow-up evaluations related to clinical study protocols.
- Administers standardized cognitive and behavioral assessment tools as defined by study requirements.
- Follows established research protocols specific to assigned clinical trials.
- Collaborates with the lead investigator to assess participant eligibility for research studies.
- Ensures accurate and compliant documentation in line with Good Clinical Practice standards.
- Executes clinical tasks according to approved procedures, regulatory requirements, and legal guidelines.
- Engages with interdisciplinary team members to support trial execution.
- Evaluates laboratory data, imaging findings, and other study-related medical reports.
- Confirms the accuracy of participant medical histories gathered by clinical staff.
- Communicates directly with participants and their designated caregivers or informants.
- Attends and completes all required training sessions within designated timelines.
- Participates in scheduled calls, webinars, meetings, and professional development activities.
- Completes mandatory education, including Good Clinical Practice and sponsor-specific training modules.
- Conducts participant interviews in alignment with FDA, GCP, ICH, and HIPAA privacy regulations.
- Stays current with relevant laws, regulations, institutional policies, and industry guidelines applicable to clinical research.
- Assists with site-level activities including recruitment outreach and participant retention strategies.
Responsibilities
- Provides participant consultations and education in an in- or out-patient setting under the direction of the PI in charge of the clinical trial.
- Conducts study-related physical exams and follow-up visits.
- Administer semi-structured test or rater scales as per protocol, not limited to CDR, ADAS-COG, MMSE, CSSRS, Cognitive Battery Test, ESS, and like validated scales.
- Reviews and adheres to assigned research study protocols.
- Works with the study-leading PI in evaluation and review of potential study participant eligibility.
- Maintains proper documentation in accordance with GCP.
- Ensures that all clinical activities are carried out in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
- Collaborates with multidisciplinary team members.
- Reviews lab results, imaging reports, and other study-specific reports.
- Reviews and verifies participant medical history collected by the Wake Research Staff/Clinicians.
- Communicates with the participant as well as the participant’s partner/informant/caregiver.
- Attend and successfully complete all training programs in a timely manner.
- Attend, participate in, and complete ongoing conference calls, webinars, required meetings, and other professional development opportunities.
- Complete required necessary training, Good Clinical Practice (GCP) training, and any Sponsor required trainings.
- Conduct participant interviews following specific study protocols, FDA, GCP, ICH, and HIPAA Privacy guidelines.
- Maintains knowledge and education of all applicable rules, regulations, policies, laws and guidelines respective to their field and role.
- Support site operations for community outreach recruiting efforts and participant retention
