Location
Coral Gables, Florida
Posted
May 16, 2018
Ref
62568469
Institution Type
Four-Year Institution
The University of Miami is considered among the top tier institutions of higher education in the U.S. for its academic excellence, superior medical care, and cutting-edge research. At the U, we are committed to attracting a talented workforce to support our common purpose of transforming lives through teaching, research, and service. Through our values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity and Teamwork (DIRECCT) we strive to create an environment where everyone contributes in making UM a great place to work. We are one of the largest private employers in Miami-Dade County; home to more than 13,400 faculty and staff from all over the world.

The Office of Research Compliance & Quality Assurance (RCQA) within the Office of the Vice Provost for Research, has an exciting opportunity for a Compliance Specialist. General Description (Purpose and Function):

The Compliance Specialist within the Office of Research Compliance & Quality Assurance (RCQA) assists with the development, oversight, and monitoring and facilitation of compliance programs. Under the direction of the Clinical Trial Disclosure Manager this position is responsible for facilitating program activities and requirements for clinical trials registration and disclosure. The objective is to facilitate Investigators and the university remain in compliance with federal, state, and local regulations and requirements.

Primary Duties and Responsibilities:

  • Provides guidance and support to research community regarding ClinicalTrials.gov database.
  • Reviews of records to assess compliance with Clinical Trial Disclosure Requirements.
    • Generates notifications to Investigators and Study teams of issues and/or errors of records.
  • Collaborates with manager in drafting, preparation, and presentation of CTD educational programs and conducts training to Investigators and study teams.
  • Assists the CTD Manager with the creation and maintenance of ClinicalTrials.gov Protocol Registration and Result Reporting (PRS) user accounts.
  • Supports CTD Manager in the facilitation of CTD Awareness associated with federal regulations and any new requirements.
  • Maintains and tracks CTD reporting and filing system.
  • Uses electronic systems (i.e. IRB7, Velos, InfoEd, RSS) for report creation and dissemination.
  • Assists the CTD Manager with the development of systems to prospectively identify and track studies with required results reporting.
  • Provides one-on-one assistance to investigators and research teams for protocol registration and results data entry.
  • Assists the CTD Manager with the development of systems to prospectively identify and track studies with required results reporting.
  • Participates and interacts with the University of Miami CTD CAPTAINs group.
  • Participates in National Clinical Trials Registration Taskforce – a monthly meeting of clinical trial registration experts at Academic Medical Centers (AMC) focusing on clinical trials registration and results reporting issues that affect US AMCs.
  • Other duties as assigned.

Knowledge, Skills, and Abilities:

  • Must be familiar with knowledge of FDA, HHS, NIH, OHRP, etc., regulations and research related guidance documents;
  • Ability to work well with Investigators and study teams.
  • Willingness to perform other related duties related to the work described herein.
  • Ability to manage multiple tasks simultaneously under minimal supervision.
  • Excellent English (verbal and written) communication skills and interpersonal skills with the ability to deal professionally with all types of information, including that of a confidential nature, required.
  • Strong organizational skills with strong attention to detail/accuracy and able to set priorities.
  • Experience with computer systems and software, including databases, spreadsheets, and word processing. Proficiency in MS Office applications.

Education Requirements (Essential Requirements):

  • Bachelor’s degree in Science, Health care, or related field.

Work Experience Requirements (Essential Requirements):

  • Three (3) years of work related research experience.
  • Professional certification in one of the following areas: clinical research, research compliance, GCP‐related field, etc., is highly desired but not a requirement.
  • Any appropriate combination of relevant education, certifications and/or work experience may be considered.
Apply online. Position #P100025105

The University of Miami is home to some of the brightest minds in the world. We are committed to educating and nurturing students, creating knowledge, and providing service to our community and beyond. The University of Miami offers competitive salaries and a comprehensive benefits package including medical and dental benefits, tuition remission, vacation, paid holidays and much more. The University of Miami is an Equal Opportunity/Affirmative Action Employer. Come join us!

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