Clin/Tran Research Coord II

Clinical/Translational Research Coord II

1912390

Your Role:

We are looking for a qualified candidate to join our growing clinical research group. Our group seeks to improve outcomes using consumer technology, particularly patient portals, to engage patients and enhance their ability to self-manage chronic medical conditions like diabetes. Our clinical research focuses on designing and testing innovative applications embedded within patient portals. We an looking for someone to coordinate our dynamic research program. Qualified candidates will have knowledge and understanding of policies, procedures, and regulations governing clinical research. They will also have strong organizational, written and oral communication, and interpersonal skills as well as be able to balance competing priorities and timelines.

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.

* 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 Epic's eStar, conducting interviews, tracking clinical data, 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/NIH prior to, during and after the conduct of a clinical/translational trial. Participates in any site visits from sponsor/NIH, regulatory authorities or others to review research, documentation and research procedures as necessary

* 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 into secure databases 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.

* 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

* With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to 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 and other health care professionals 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, 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

* Assists the Principal Investigator in managing and supervising research staff including research assistants, clinical research associates, etc. Trains and mentors new staff to perform job duties at an acceptable level and understand new processes and regulations.

* Organizes research team meetings and prepares documents, slides and meeting summaries.

* 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

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