Clinical Research Coordinator, LVN or RN

Study Research Nurse/Coordinator Job Description GENERAL DESCRIPTION The primary responsibility of the study research nurse/coordinator is to manage all aspects of conducting clinical trials/ research studies. 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 nurse/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 nurse/coordinator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the nurse/coordinator is responsible for all data and source documentation, adverse experience reporting, and maintenance of complete regulatory files. QUALIFICATIONS Licensed Vocational Nurse with a current license to practice, and at least one (1\) year of clinical research\-related experience, IV certification required. Registered Nurse with a current license to practice, and at least one (1\) year of clinical research\-related experience CRITERIA FOR EVALUATION A. Sound conduct of the clinical trial, including but not limited to recruitment, screening, enrollment, and follow\-up of eligible subjects according to protocol requirements (e.g., subject follow\-up, case report form completion, and reporting of adverse drug experiences). B. Maintenance of accurate and complete documentation, including not but limited to regulatory documents, signed informed consent forms, relevant IRB approvals, source documentation, drug dispensing logs, subject logs, and study\-related communications. C. Organizational management of all aspects of the trial, including but not limited to timeliness in completing case report forms (CRFs), data entry, reporting adverse drug experiences (ADEs), managing case load and managing study files. D. Communication of all protocol\-related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial, concerns regarding possible AEs or subject compliance. E. Professional conduct in the presence of subjects, research staff, sponsors, monitors, etc. ESSENTIAL JOB FUNCTIONS: A. Develop enrollment/follow\-up mechanisms 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. Review the protocol summary sheet and the informed consent form for accuracy and clarity. d. Develop draft protocol follow\-up worksheets and then review the worksheets for accuracy and clarity. e. Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate. f. Prepare IRB applications and ongoing amendments, as directed. B. Enrollment and follow\-up of study subjects a. Screening and enrollment procedures i. Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility. ii. Review the protocol, informed consent form, and follow\-up procedures with potential study subjects. iii. Ensure the current approved informed consent is signed before subjects are screened and enrolled. iv. Ensure that the randomization procedure is followed as per protocol guidelines. v. Document protocol exemptions and deviations, as appropriate. b. Subject follow\-up procedures i. Ensure adherence to protocol requirements. ii. Schedule subjects for follow\-up visits. iii. Assess subject response to therapy and evaluate for adverse events. iv. Review laboratory data and communicate abnormal values to the investigator. v. Assess and document subject compliance with medications and visits. vi. Eassure timely and accurate study drug distribution. vii. Administer study drug therapy as needed and maintain the study drug dispensing log. viii. Maintain copies of all documentation written for study drug supplies, as appropriate. ix. Ensure appropriate specimen collection. x. Attend study\-related meetings as appropriate. xi. Communicate regularly with the principal investigator about study\- related issues. c. Case report form (CRF) preparation and study documentation i. Ensure timely and accurate CRF completion for each study subject. ii. Key data for remote data entry or provide completed CRFs on a timely basis. iii. Review keyed data for accuracy as needed. iv. Maintain source documentation for all CRF entries, including clinic chart visit notes, lab data, and procedure reports. v. Provide auditors with completed CRFs, medical records, lab data and other source documents for review. vi. Correct and edit CRFs, as appropriate. d. Adverse experience monitoring and reporting responsibilities i. Assess and record all AEs as outlined in protocol. ii. Report all serious AEs to the principal investigator, sponsor’s monitor, and IRB as outlined in the protocol. e. Regulatory documentation i. Maintain copies of all required regulatory documents. ii. Prepare IRB submissions, protocol revisions, and renewals as needed, and maintain copies of all IRB communications. f. Sponsor and/or FDA audits i. Ensure that all required documentation is complete and appropriately filed. ii. Provide all required documentation to auditors. iii. Make all appropriate corrections as requested by auditors. g. Study close\-out i. Ensure that all study documentation (regulatory, IRB communications, patient and drug logs, etc.) is appropriately filed. ii. Ensure that all CRFs are complete and that all forms have been forwarded to the sponsor or entered into the computer, as appropriate. iii. Store all files in a permanent and safe location. iv. Notify the IRB of the study's completion, according to IRB procedure. h. Management of ancillary staff i. Train and supervise support staff (e.g., research assistants, clerical staff and volunteers). Job Type: Full\-time Pay: $55,000\.00 \- $65,000\.00 per year Benefits: Flexible schedule Paid time off Application Question(s): Are you currently located in the Greater Houston area? License/Certification: LVN License (Required) IV Certification (Required) RN License (Preferred) Work Location: In person