CLINICAL RESEARCH NURSE COORDINATOR II
2 weeks ago
General Responsibilities
* To serve as primary coordinator for clinical research studies and supporting more senior team members.
* To provide a lead role in protocol screening and participant eligibility determination working alongside other team members to ensure compliance.
* May provide oversight to junior clinical research coordinators (CRC) and clinical research nurse coordinators (CRNC) in review of study documents.
* To conduct all study activities in accordance with the protocol, Institutional Review Board (IRB) regulations, and Good Clinical Practice (GCP).
* To provide quality care to participants and their families within the area of clinical specialty.
* To coordinate the life cycle of the study from start-up through maintenance to closure.
* To manage participant care including recruitment, screening, scheduling, consenting, conducting visits, and collecting various assessments such as adverse event (AE) information or questionnaires.
* To perform the informed consent process following GCP.
* To act as a liaison between the clinical and research staff, departments, ancillary services and the study sponsor to ensure protocol compliance throughout the study.
Primary Responsibilities
* Conducts protocols pertaining to human research under the direction of PIs.
* Coordinates and oversees the implementation of clinical research studies according to established standards and protocols.
* Recruits, retains, enrolls human subjects keeping NIH and lab timelines.
* Ensures compliance with regulatory requirements, including HIPAA guidelines.
* Manages and maintain accurate and up-to-date study documentation.
* Performs data management tasks, including data entry, analysis, and reporting.
* Conducts human studies with appropriate use of SOPs, program manuals follow through using proper GCP and Human subject's protection guidelines, and document work appropriately in electronic folders.
* Places IVs, prepare medications, and conduct studies in the Clinical Research Unit at UAB.
* Adheres to institutional policies, attention to research safety and integrity; safety of participants comes first.
* Collects and records patient data, including vital signs and medical history.
* Assists with blood sampling and phlebotomy procedures as needed.
* Monitors study participants for adverse events and report findings to the appropriate parties.
* Maintains confidentiality of patient information and study data.
* Collaborates with healthcare professionals, including nurses and physicians, to ensure proper patient care during research studies.
* Submission for IRB, radiation safety, and CCTS approvals as needed.
* Submission for FDA -IND/IDE, other regulatory work as per PI.
* Prepare annual enrollment reports for NIH, FDA, and others.
* Work under the supervision of MDs and other post-doctoral fellows.
* Performs other duties as assigned.
Annual Salary Range - $60,835 - $98,855
Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement. Currently licensed as a Registered Nurse (RN) by the Alabama Board of Nursing required.
Preferred Qualifications
* Certification by SOCRA is a plus.
* Strong working knowledge of clinical research processes, regulations, and guidelines.
* Strong attention to detail and organizational skills.
* Excellent communication and interpersonal skills.
* Ability to work effectively in a team environment.
* Proficiency in using computer systems for data management and analysis. Familiarity with phlebotomy procedures is a plus.
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