Clinical Research Coordinator

Job Description:

Baptist Health is looking for a Clinical Research Coordinator to join our team in Lexington, KY

Under limited supervision, the Clinical Research Coordinator I (CRC) coordinates patient care in compliance with local, state and federal guidelines and regulations through IRB approved protocol requirements. The CRC uses their developing and/or basic knowledge of clinical trial research along with their hospital experience to work collaboratively with individuals associated with the care and treatment of the patient. It is the expectation the CRC will utilize day-to-day experience and collaborations with senior staff to broaden their knowledge base and capabilities. They will seek out opportunities to build their knowledge of the organization, research processes and scope of work. They will understand the guidelines, regulations, and policies associated with conducting clinical trial research and use that insight to evaluate and resolve problems or seek out guidance. The CRC collaborates with the investigators, research staff and other departmental stakeholders to conduct clinical trial coordination per protocol. Through clear documentation, the CRC will define any changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study intervention. The CRC works collaboratively with individuals associated with the care and treatment of the patient.

Essential Duties:

• Coordinates and organizes multiple activities of clinical studies and/or trials.

• Enrolls subjects appropriately to each protocol assigned as well as coordinates and/or schedules all necessary study participant activities as required by the protocol.

• Screens all appropriate patients for clinical trial participation.

• Obtains informed consent for research protocol prior to any research procedures performed.

• Provides a working knowledge and experience in one or more fields in clinical research to community-based health care personnel related to study participation.

• Through effectively performing and/or capturing data needed to facilitate the investigators' ability to efficiently evaluate patients (including but not limited to EKGs, phlebotomy, vital signs, current medications, adverse event assessment, device or drug accountability and calculating drug dosages), provide protocol specific guidance for the preparation and administration of study drug or device usage.

• Provides protocol specific guidance to appropriate staff to ensure research related care to study participants is according to the protocol.

• Documents accurately all research related activity including patient follow-up in accordance with the protocol specific requirements, hospital policy, established standards, culture and age of study participant is served. Completes follow-up activity within acceptable as established per protocol.

• Demonstrates knowledge of Food and Drug Administration (FDA) regulations, International Conference on Harmonization Good Clinical Practice (GCP), institutional, hospital policies and other applicable regulations, guidance's and policies related to clinical research and human subject protection.

• Attends all required safety training programs and can describe his/her responsibilities related to general safety, department/service safety, specific job-related hazards, and national patient safety goals.

• Acts as a clinical resource for certified medical assistants, clinical nurses, investigational pharmacist, and other staff regarding patient problems and clinical trial related tasks for study subjects. Communicates regularly with investigators, related staff, and all applicable stakeholders.

• Meets commitments on a consistent basis including those to patients, team members, and all other stakeholders.

• Participates in preparation of IRB submissions as requested.

• Assists in assuring the current version of protocols are utilized by timely submission of amendments, adverse events, continuing approval, or closure documentation.

• Communicates regularly with Principal Investigator, sub-investigators, sponsor, hospital and office staff, hospital departments and Research AVP/Director/Managers regarding study activities including, recruitment, enrollment activity, and operational issues.

Minimum Education, Experience, Training and Licensures Required

• Technical diploma in biology, public health, pharmacy, or health related field.

• Three years of clinical experience in an area of research focus.

• Completion of BLS/ACLS training within 6 months of obtaining role.

• Previous experience in clinical research or as a clinical trial coordinatorpreferred.

• Proficient with a computer including navigating websites, electronic data systems, electronic medical records, Excel, Word, PowerPoint preferred.