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CLINICAL RESEARCH COORD

Company: St. Luke's Hospital
Location: Chesterfield
Posted on: May 6, 2022

Job Description:

Description:The primary responsibility of the Clinical Research Coordinator is to manage all aspects of conducting clinical trials under the direction of the Principal Investigator. The Research Coordinator is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the Research Coordinator will act as liaison between the investigators, primary care providers, the institutional review board (IRB) and the sponsor. Along with the investigator, the Research Coordinator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the Coordinator is responsible for all data and source documentation, adverse experience reporting and maintenance of complete regulatory files. Performs duties and responsibilities in a manner consistent with St. Luke's mission and values.
Principal Accountabilities: % Of Time Spent
1. Develop Enrollment / Follow-up Mechanisms: (10%)a. Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility.b. Review with the Principal Investigator the Inclusion/Exclusion Criteria, overall structure and requirements of each protocol.c. Complete the Protocol Summary Sheet and the Informed Consent Form for accuracy and clarity.d. Develop protocol follow-up worksheets and then review the worksheets for accuracy and clarity.e. Develop a mechanism for subject recruitment and on-going communications with Primary Care Physicians and nursing staff, as appropriate.f. Prepare IRB applications and on-going amendments.
2. Enrollment and Follow-up of Study Subjects: (20%)a. Screening and Enrollment Procedures i. Review the study design and Inclusion / Exclusion Criteria with the subject's Primary Physician. ii. Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility. iii. Review the protocol, informed consent form and follow-up procedures with potential study subjects. iv. Ensure the current approved informed consent is signed before subjects are screened and enrolled. v. Ensure that the randomization procedure is followed as per protocol guidelines. (20%) vi. Document protocol exemptions and deviations, as appropriate.b. Subject Follow-up Procedures
1. Ensure adherence to protocol requirements.2. Facilitate subjects for follow-up visits.3. Assess subject response to therapy and evaluate for adverse events with sub-investigators and Principal Investigator.4. Review laboratory data sub-investigator and Principal Investigator.5. Assess and document subject compliance with medications and visits.6. Communicate with Pharmacy staff to assure timely and accurate study drug distribution.7. Maintain copies of all prescriptions written for study drug supplies, as per Pharmacy Policy.8. Ensure appropriate specimen collection.9. Attend study-related meetings, as appropriate. (10%)10. Communicate regularly with the Principal Investigator about study-related issues.
C. Case Report Form (CRF) Preparation and Study Documentation1. Ensure timely and accurate CRF completion for each study subject.2. Submit completed CRFs on a timely basis.3. Maintain source documentation for all CRF entries, including clinic chart visit notes, lab data and procedure reports.4. Provide auditors with completed CRFs, medical records, lab data and other source documents for review. (20%)5. Correct and edit CRFs, as appropriate.
D. Adverse Experience Monitoring and Reporting Responsibilities1. Assess and record all SAEs as outlined in protocol.2. Report all serious SAEs to the Principal Investigator, the IRB and others, as outlined in the protocol. (5%)
E. Regulatory Documentation1. Maintain copies of all required regulatory documents.2. Prepare IRB submissions, protocol revisions and renewals, as needed, and maintain copies of all IRB communications. (5%)
F. Sponsor and/or FDA Audits1. Ensure that all required documentation is complete and appropriately filed.2. Provide all required documentation to auditors. (5%)3. Make all appropriate corrections as requested by auditors.
G. Study Close-out1. Ensure that all study documentation (regulatory, IRB communications, patient and drug logs, etc) is appropriately filed.2. Ensure that all CRFs are complete and that all forms have been forwarded to the sponsor or entered into the computer, as appropriate.3. Store all files in a permanent and safe location.4. Notify the IRB of the study's completion, according to the IRB procedure. (5%)
H. Management of Ancillary Staff1. Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).
TOTAL 100%Education:Must have one of the following:1. Current licensure as a Registered Nurse in the state of Missouri Required. Nursing Diploma or Associates in Nursing Required.2. Bachelor's degree in health-related field and at least 3-5 years of clinical research-related experience3. Masters degree in a related field or 2 years clinical research-related experience
Experience:Must have one of the following:1. Current licensure as a Registered Nurse in the state of Missouri Required. Nursing Diploma or Associates in Nursing Required. BSN or completion of BSN within 5 years of hire date is required.2. Bachelor's degree in health-related field and at least 3-5 years of clinical research-related experience3. Masters degree in a related field or 2 years clinical research-related experience
Mission/Values:MissionFaithful to our Episcopal-Presbyterian heritage and its ministry of healing, St. Luke's is dedicated to improving the health of the communities we serve.
Using talents and resources responsibly, we provide high quality, safe care with compassion, professional excellence and respect for each other and those we serve.
VisionAs an independent healthcare network, we create healthy communities in the region through our commitment to high quality, safe and personalized services.
Core Values
Human DignityWe accept and treat all persons as being created in the image of God.
CompassionWe respond with caring to the needs of others as if they were members of our family.
JusticeWe honor each person's rights and responsibilities in light of the common good.
ExcellenceWe set and strive to attain high standards of performance and continuous improvement.
StewardshipWe use our talents and resources wisely, with honesty and integrity.

Keywords: St. Luke's Hospital, Chesterfield , CLINICAL RESEARCH COORD, Healthcare , Chesterfield, Missouri

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