Clinical Research Associate - Nurse
Holy Cross

Job Info

Employment Type:
Full time
Shift:
Day Shift

Description:
This person will be responsible for the conduct of multiple clinical research activities. Ideal candidate will have industry sponsored clinical trial experience and/or project management experience for investigator initiated projects. Person is able to work with minimal supervision and within the scope of clinical research protocols, participates in research activities which may include: subject recruitment, confirmation of subject eligibility, informed consent process, completion of case report forms, data clarification, IRB preparations, chart abstraction, hosting monitor visits, organizing site initiation visits. Person will be responsible for leading and managing the project from the standpoint of clinical research activities. Must be knowledgeable on and have full understanding of good clinical practices (GCP) and regulations. Must adhere to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources. Experience with clinical trials and industry sponsored studies preferred.
Job Requirements:

+ Serve as clinical nursing knowledge role model in the care of research participants.
+ Perform clinical assessments of research participants, including blood pressure, heart and respiratory rates, brief physical exams, EKGs, and other clinical testing appropriate within the RN scope of practice, i.e., NIH Stroke Scale, NYHA and CCS class.
+ Perform clinical procedures per research protocols, including blood draws, injections, and other procedures appropriate within the RN scope of practice.
+ In conjunction with the PI and other facility/clinic staff, may provide direct patient care related to the research protocol.
+ Report change in research participant condition to PI and appropriate personnel in a timely manner.
+ With minimal guidance, implement clinical trials and research projects that meet Holy Cross Hospital (HCH) and facility/clinic objectives, and ensure compliance with protocol and sponsor requirements and all aspects of U.S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, as well as DHRI requirements.
+ Assist the Clinical Research Manager or designee, PI, sponsors/CROs in identifying and evaluating potential new trials for feasibility of implementation at the site; provide recommendations. Complete clinical portions of sponsors' feasibility questionnaires.
+ Prepare, manage and submit all required any required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or HCH.
+ Attend local appropriate clinical department meetings, as needed, for presentation of new protocols for review.
+ Coordinate and participate in site initiation and other sponsor-required training for all protocols.
+ Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials.
+ To ensure protocol adherence, accurate data collection and billing compliance, instruct/advise Principal Investigator (PI) and other health care providers in the hospital/ clinic setting as to protocol-required tests and procedures to be conducted at each visit.
+ Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements.
+ Obtain PI signatures on all required study documents.
+ Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
+ Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility.
+ Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies.
+ Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff.
+ Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations.
+ Work with HCH Research billing staff to ensure clinical trials are performed in accordance with HCH requirements; update data in the designated CTMS for all participant visits.
+ Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and HCH policy.
+ Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.
+ Serve as liaison between participants, physician investigators, sponsors of research, IRBs, HCH Research administration, and patient care coordinators to assist in protocol interpretation, clinical and safety questions.
+ Complete progress notes accurately, and in a timely manner.
+ Attend investigator/coordinator meetings as required by study sponsors.
+ Flex work schedule as needed to accommodate participant visits, sponsor deadlines or program needs; work hours as needed--which may exceed 40 hours per week--based on workload and deadlines.
+ Complete professional and clinical education annually.
+ Meet all mandatory requirements of the position including mandatory training, classes, licensure/certification, employee health requirements, and adherence to HCH's Code of Conduct.
+ Other duties as assigned

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