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Clinical Research Coordinator II-Otolaryngology 

 

TN-Nashville-Medical Center East (MCE) - South Tower
 

Shift First Shift

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JOB SUMMARY

Responsible for coordinating the approval processes and conduct of research protocols, assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. Manages screening, implements recruitment procedures, consent, enrollment, randomization and study conduct from planning through study closeout. Performs or implements processes to assure study-related procedures are performed as required and objectives and timelines are met. Maintains accurate and timely documentation and communication with Investigators, participants, IRB, sponsors and other research related entities.

 

Additionally accountable for coordinating several studies examining the pathogenesis and treatment of sleep apnea. Manages and oversees protocols by assisting principal investigator with the administration, management and coordination of projects and cores. As a licensed sleep technologist, prepares and monitor participants under the supervision of for testing by applying sensors to monitor physiological parameters during sleep in the Clinical Research Core Sleep Laboratory (i.e. brain wave (EEG), heart rate (EKG), eye movements (ECG), leg movements (PLM), oxygen saturation(SO2), pressure tranducer and nasal thermistor, positive airway pressure, and respiratory inductance plethysmography to monitor sleep-disordered breathing. In addition, collection of specialized physiologic measurements ((e.g. end  tidal CO2, esophageal pressure recordings, genioglossal muscle monitoring). Terminate study in morning by removal of sensors, administering morning questionnaire, instructing participant with respect to follow-up. Nighttime work will be required 1 week/month and may occasionally involve weekend nights.

 

RESPONSIBILITIES

  • Responsible for the conduct of research testing in the laboratory setting. Analysis of collected sleep studies using standard sleep scoring criteria and research criteria (learned on the job). Prepare data summary reports using software packages that are available in the laboratory.

  • Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research

  • Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations

  • Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations

  • Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations

  • Understanding and capability to accurately and compliantly perform the procedures required of each study protocol, working collaboratively with study participants, other staff and departments, in safely and accurately performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage, etc. Ability to identify and troubleshoot problems

  • Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures

  • Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)

  • Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation

  • Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures

  • Knowledgeable of the safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes

  • Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation

  • With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies

  • Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants

  • Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation

  • Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial

  • Engages in open communication with participants by providing them with contact information and being available to answer, address or refer their calls

  • Performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reporting as required by policy, regulations or protocol, to the sponsor and regulatory agencies

  • Utilizes or acquires knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations

  • Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, etc.)

  • Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work

  • Engages in a minimum of 10 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification

  • Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor

  • Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel

  • Furthers knowledge by completing more advanced job-related educations (such as Research Support Services Boot camp Follow-up). Actively seeks new learning opportunities, seeing learning as a part of work. Develops and achieves personal and professional goals

 

QUALIFICATIONS

  • Bachelor's Degree (or equivalent experience) (Required)

  • 2 years experience (Required)

  • Certification as a registered polysomnography technologist (RPSGT) by the Board of Polysomnographic Technologists (BRPT). Previous experience as a polysomnograph technician for at least 3 months is preferred; work experience with sleep software programs is desirable.

  • Prior to advancing to a Clinical/Translational Research Coordinator II, must have completed a Research 101 course such as RSS Boot camp; applicant/new hire must complete a Research 101 course within six (6) months of hire.

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Bachelor's Degree (or equivalent experience) and 2 years experience

 

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