Assistant Regulatory Coordinator

Drug Information Association Inc Nashville , TN 37201

Posted 2 months ago

Internal Number: 2112531


Assistant Regulatory Coordinator

Job Summary:

Under the supervision of the Senior Manager of Regulatory Affairs within the Clinical Trials Office, the Assistant Regulatory Coordinator (ARC) supports the clinical research efforts of the Vanderbilt-Ingram Cancer Center by providing regulatory support for Investigators, in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and Medical Center policies and procedures.

The NCI-designated Vanderbilt-Ingram Cancer Center (VICC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care. VICC provides research resources to its engaged faculty and offers multidisciplinary cancer care to its patients.

Responsibilities related to regulatory coordination activities include preparing and processing the collection of regulatory documents from study start-up through the life of the study and as needed, will additionally help with the submission of modifications, renewals, adverse events, and study closures to the Institutional Review Board (IRB).

In addition, the ARC serves as the liaison to sponsors and facilitates transmission of verbal and written communication to National Clinical Trials Network (NCTN) groups, pharmaceutical companies, and other research entities, as needed. The incumbent is also responsible for the maintenance of our NCTN and ETCTN study rosters.

The incumbent must accurately maintain regulatory information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).

Department/Unit Summary:

Vanderbilt-Ingram Cancer Center (VICC) is a leader in the prevention, diagnosis and treatment of cancer. The centers world-renowned team of experts provides a integrated, personalized and patient-centered approach to cancer care, including treatment, research, support, education and outreach. From a wide variety of wellness programs to a leading REACH for Survivorship Clinic, patients find support from diagnosis through survivorship. VICC is a National Cancer Institute-designated Comprehensive Cancer Center, one of just two centers in Tennessee and 51 in the country to earn this highest distinction, and ranks in the top 10 nationwide for cancer research grant support. Here is a link to our website -

Position Shift:

  • First Shift

View how Vanderbilt Health employees celebrate the difference they make every day:

Discover Vanderbilt University Medical Center:

Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded and your abilities challenged. It is a place where your diversity -- of culture, thinking, learning and leading -- is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.

VUMC Recent Accomplishments

Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:

  • US News & World Report: #1 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.

  • Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.

  • Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.

  • The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.

  • American Association for the Advancement of Science: The School of Medicine has 112 elected fellows

  • Magnet Recognition Program: Received our third consecutive Magnet designations.

  • National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement

  • Human Rights Campaign Healthcare Equality Index: 6 th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.

Additional Key Elements/ Responsibilities:
  • 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

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Associate Regulatory Affairs

Cumberland Pharmaceuticals

Posted 3 days ago

VIEW JOBS 10/25/2021 12:00:00 AM 2022-01-23T00:00 <p>1. Manage the receipt, maintenance, approval, submission, and distribution of documents including nonclinical and clinical trial master files, adverse drug experiences, product complaints, regulatory submissions/correspondence, batch records and standard operating procedures; </p><p>2. Control electronic templates for regulatory, professional affairs and clinical documents and SOPs; </p><p>3. Initiate new SOPs, revise existing SOPs and manage SOP review process as required and as they relate to operations departments; </p><p>4. Liaise with Professional Affairs and Regulatory departments to ensure compliance with regulatory reporting/submission deadlines;</p><p> 5. Coordinate publishing activities for all FDA submissions; </p><p>6. Review advertising and promotional materials;</p><p> 7. Coordinate package insert and other labeling for SPL submission;</p><p> 8. Coordinate regulatory documentation between CPI and international partners </p><p>9. Manage IND and NDA annual reports;</p><p> 10. Manage PDUFA and NDC activities; </p><p>11. Coordinate regulatory documentation between Cumberland and international partners </p><p>12. Other projects or duties, as assigned</p><p><strong>Requirements</strong></p><p>Must be able to handle several projects simultaneously, be detail oriented and extremely organized. Skilled in the use of word processing, spreadsheet, email, and database software. Experienced in drug development strategy. Experienced in eCTD submissions for INDs and NDAs. Job is based in Nashville corporate office</p> Cumberland Pharmaceuticals Nashville TN

Assistant Regulatory Coordinator

Drug Information Association Inc