Clinical Research Associate

ORGANIZATIONAL SUMMARY:

The Department of Obstetrics and Gynecology is committed to delivering the highest quality and most compassionate patient care, training highly competent and caring clinicians, and generating the most innovative research. To these ends, we provide up to date clinical services to care for women at all stages of their lives. Our faculty represent a group of dedication physicians and research scientists who are well recognized as leaders in all three mission, clinical care, research and education. We also place at the top of our priority list the educational activities within the College of Medicine; including education of fellows, residents and medical students.  In ObGyn, we strive for a culture which recognizes and rewards an academic entrepreneurial spirit, productivity, teamwork, integrity and kindness.

POSITION SUMMARY:

The Clinical Research Associate will coordinate, conduct and evaluate research related activity for clinical research projects as assigned. The primary purpose of this position is to oversee the screening, enrollment and retention of study participants in the IMPACC clinical trial. This involves enrolling and collecting both biologic specimens along with matched clinical demographics and complex clinical outcome metadata at pre-specified timepoints. Biologic specimens will be used to prepare multiple complex bioanalytes on site, which will be batched and shared with multiple analysis centers throughout the U.S. This work involves many aspects of a traditional clinical research coordinator - arranging and facilitating timed study visits, ensure quality of data collected throughout the research study, and implement the procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Director of Clinical Research & Principal Investigator.

RESPONSIBILITIES:

Recruit, screen and provide research related services, interventions and evaluations per protocol for participants enrolled in clinical research studies under the direction of the Principal Investigator (PI). Provide initial and ongoing informed consent with participants and families. Schedule study visits and procedures and follow-up study visits per protocol visit windows. Administer investigational product per protocol. Perform study related procedures such as collection of vital signs, phlebotomy, injections and other procedures per protocol as delegated by the PI and in accordance with training and experience. Communicate participant status to Investigator and research team as well as other entities as required. Strive to enhance subject retention in assigned protocol. Assure all reporting requirements are met per regulatory and institutional policies and procedures. Track and report participant study visit activity and procedures for assigned protocols.

Compile and maintain research progress notes and source documents and record data for each study participant in accordance with the research protocol. Monitor participant's unexpected and adverse events, laboratory, radiology, and other procedure test results and report to Investigator, sponsor and IRB (Institutional Review Board) as appropriate. Collect and report study data on paper Case Report Forms or in electronic data capture systems per protocol, including query resolution. Develop source document templates as needed per protocol. Monitor clinical study activity to ensure compliance with the protocol, site SOPs (Standard Operating Procedures) and all applicable regulations, including HIPAA (Health Insurance Portability and Accountability Act) regulations.

Prepare and submit documents to the Institutional Review Board(s) and other research review boards and committees as applicable and according to regulatory and institutional requirements. Compile and maintain regulatory files for assigned protocols but also many of the responsibilities of a research laboratory technician in terms of the preparation of bioanalytes. Specific skills required will include the  preparation of serum, CyTOF-suitable blood and sputum specimens and in the isolation and recovery of PBMC fractions from the buffy coat of blood. Lastly, this individual will be involved in the processing, management, preparation and shipment of specimens to achieve comprehensive project objectives.

Collect, process and ship research specimens. Achieve and maintain certification in biohazardous materials shipping. Ensure that infection control and safety procedures are implemented and maintained. Maintain investigational article accountability records and manage clinical su