LIBR Clinical Research Coordinator

3 days ago

Tulsa, United States Saint Francis Health System Full time
Current Saint Francis Employees - Please click HERE to login and apply.

Full Time

8:00a - 4:30p

Schedule: Monday - Friday | 8:00am - 4:30pm

Job Summary: The Clinical Research Coordinator is responsible for the management and running of assigned research studies under the direction of the Principal Investigator.

Minimum Education: Has completed the basic professional curricula of a school of nursing as approved and verified by a state board of nursing, and holds or is entitled to hold a diploma or degree therefrom.

Licensure, Registration and/or Certification: CPR certificiation. Valid multi-state or State of Oklahoma Registered Nurse License or Licensed Practical Nurse certification, preferred.

Work Experience: 1 year previous psychiatric nursing and/or clinical research experience preferred.

Knowledge, Skills and Abilities: Basic computer skills and knowledge of Microsoft Office Suite (Word, Excel). Ability to function as a team member. Ability to perform basic nursing procedures such as phlebotomy, vital signs, and other tests specific to the study and may also administer treatments specific to research studies. Ability to interact with patients and families to ensure study compliance and obtain information. Ability to communicate with physicians regarding patient's response to treatment and/or medications, adherence to protocol's schedule, need to reevaluate treatment, and specific medical concerns. Ability to work with considerable independence under general supervision. Excellent interpersonal and communication skills as needed to work with professional staff and study participants.

Essential Functions and Responsibilities: 1. Responsible for recruitment, screening and scheduling of all potential study participants. Ensures that all study visit documentation and/or assessments are completed. Completes and maintains Case Report Forms, Clinical Trial Regulatory Binder(s), and source documents. 2. Prepares and submits new study protocols, applications, study documents, consents, and deviation reports / Corrective Action Plans to the IREB and the sponsor for approval. Submits study changes and continuing review to IREB. Submits to the IREB and study sponsor all serious and/or unexpected adverse events documentation. Provides follow-up as required. 3. Interacts and serves as a resource to the Principal Investigator, investigators, sponsor, research staff and other entities involved with the study. Provides training as required. 4. Performs electrocardiograms (ECGs), phlebotomy procedures, prepares laboratory specimens, and other tests are required. As requested, trains research staff in the performance of clinical procedures. Ensures adequate levels of study drugs, study forms, laboratory kits, ECG supplies and any other study related supply is maintained. 5. Complies with FDA, state, and local regulations and guielines for conducting clinical trials. Assures all study documents are maintained and archieved per sponsor, IREB, and FDA regulations. Participates in required sponsor meetings, certification and/or IREB education. Coordinates and participates in monitoring visits. Resolves sponsor data queries in specified time frame. 6. Performs basic nursing procedures such as phlebotomy, vital signs, and other tests specific to the study and may also administer treatments specific to research studies. In addition, the incumbent will inform physicians regarding patient's response to treatment and/or medications, adherence to protocol's schedule, need to reevaluate treatment, and specific medical concerns. Other duties will include managing data collection; obtaining, verifying, organizing, coding and entering data; completing forms and maintaining files; assisting in patient recruitment; explaining study to patients and potential patients and verifying eligibility; and ensuring that all applicable forms and other required paperwork are completed. 7. Other duties will include managing data collection; obtaining, verifying, organizing, coding and entering data; completing forms and maintaing files; assisting in patient recruitment; explaining study to patients and potential patients and verifying eligibility; and ensuring that all applicable forms and other required paperwork is completed.

Decision Making: The carrying out of non-routine procedures under constantly changing conditions, in conformance with general instructions from supervisor.

Working Relationship: Coordinates activities of others (does not supervise). Leads others in same work performed (does not supervise). Works directly with patients and/or customers. Works with internal customers via telephone or face to face interaction. Works with external customers via telephone or face to face interaction. Works with other healthcare professionals and staff. Works frequently with individuals at Director level or above.

Special Job Dimensions: None.

Supplemental Information: This document generally describes the essential functions of the job and the physical demands required to perform the job. This compilation of essential functions and physical demands is not all inclusive nor does it prohibit the assignment of additional duties.

Laureate Institute for Brain Research - Laureate Campus

Location:
Tulsa, Oklahoma 74136

EOE Protected Veterans/Disability

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