Job Details
The University of Alabama at Birmingham (UAB), School of Medicine, Division of Clinical Immunology and Rheumatology, is seeking a Clinical Research Coordinator III to independently coordinate and perform duties related to initiating and implementing research projects: screening and enrolling participants in rheumatology observational studies and clinical trials, conduct informed consent per GCP guidelines, conduct patient screening and enrollment, conduct patient visits per protocol, document adverse events, medications, and procedures conducted at each visit, prepare lab kits for each patient visit, administer study questionnaires, and other procedures as trained. The CRC III will submit regulatory protocols and documents, collect and organize study information and enrollment data, develop and implement study procedures, maintain records, track progress, and conduct quality assurance on data collected. This position will serve as a mentor to junior staff, conduct protocol training, assist PI in developing research proposals (including but not limited to research plans, study synopsis, human subject protocols, and other ancillary documents such as letters of support), regulatory protocols and documents, as well as attend team meetings and educational training as required.
General Responsibilities
* To manage all aspects of assigned clinical studies including education.
* To develop protocol-specific systems and documents.
* To act as a consultant within area of clinical expertise.
* To identify various stakeholders to ensure adequate design, implementation, and testing of study aims.
* To assess and determine solutions for operational shortcomings for data procurement in protocol design.
* To maintain familiarity with appropriate Good Clinical Practice (GCP) guidelines and regulations.
Key Duties & Responsibilities
* Provides a lead role in protocol screening and participant eligibility determination working alongside other team members to ensure compliance.
* Provides oversight to clinical research coordinators (CRC) I and II in review of study start-up, SIV planning (site visits), subject management, data query resolution and source document development including review of study documents including but not limited to flowsheets, pharmacy orders, labs, and adverse events. May lead CRCs and CRNCs.
* Responsible for conducting all study activities in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).
* Under the oversight of the Investigator and clinical research administrator, develops protocols, identifies efficiencies, and improves processes. Arrange multidisciplinary evaluations.
* Maintains compliance with federal, state, and accrediting agencies (sponsors). Maintains any required documentation.
* Manages site supplies as needed.
* Maintains compliance with federal, state, and accrediting agencies (sponsors).
* Maintains any required documentation.
* Serves as a mentor to junior staff, including student assistants.
* Performs other duties as assigned.
Annual Salary Range: $60,835 - $98,855
Bachelor's degree in a related field and five (5) years of related experience required. Work experience may NOT substitute for education requirement. Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred.
Preferences
* Ability to lead others in the coordination of research activities in conducting observational and clinical trials.
* Knowledge of clinical and regulatory/compliance affairs.
* Excellent working knowledge of related scientific and clinical terminology.
Key Skills
* Strong problem-solving skills.
* Leadership skills.
* Professional presentation skills.
* Excellent prioritization and organizational skills.
* Excellent written and verbal communication skills.
* High emotional intelligence.
* Ability to work in a team environment successfully.
* Attention to detail.