Following detailed instruction will screen recruit and enroll participants for assigned studies by interviewing potential participants and reviewing medical history to determine if eligibility requirements are met.
Under direction will inform and instruct study participants concerning research protocol and complete the patient informed consent procedure.
Under direction of PI assist with coordinating and and/or performing research testing per protocol such as drawing blood vital signs EKGs etc. includes processing and packaging of laboratory samples for shipment.
With detailed instruction assess participants during research visit perform initial review of study lab results assess for any side effects or other problems notify principal investigator of any participant reported side effects or problems.
With detailed instruction complete case report forms for each study participant and document medical data in the patient record and sponsor database. Ensure case report forms or other data collection/tracking tools are created if not provided by sponsor.
Assist PI with sponsor site visit and audits for assigned studies including escorting visitors and providing requested documentation.
Provides weekend and evening support for team coordination communication etc. to meet study protocol requirements.
Knowledge, Skills, and Abilities:
• Demonstrated excellence in written and verbal communication. • Ability to interpret and analyze data. • Demonstrated ability to collaborate effectively with peers, patients, management, and internal and external stakeholders fostering professional relationships that support operational efficiency, patient-centered service, and cross-functional project success. • Knowledge of the principles, practices, and techniques of clinical research skills. • Proven ability to provide high-quality, compliant research and ethical standards.