CLINICAL RESEARCH COORDINATOR III

The University of Alabama at Birmingham (UAB), Civitan International Research Center, is seeking a Clinical Research Coordinator III.

General Responsibilities

• To serve as a lead coordinator by providing oversight to less experienced staff to ensure quality and regulatory compliance with clinical research operations.
• To coordinate and manage the research study lifecycle from start-up through close-out.
• To coordinate and conduct all applicable clinical and administrative activities required by the protocol such as screening, scheduling, consenting, assessing, ordering, collecting, documenting and shipping under the auspices of Good Clinical Practice (GCP).

Key Duties & Responsibilities

1. Manages all aspects of the research program and clinical studies, including education/training. Develops protocol-specific systems and documents, including process flows, training manuals, SOPs, and CRFs. Prepares study budgets as needed. Coordinates studies of all complexities. Acts as a consultant within the area of clinical expertise.
2. Provides a lead role in determining participant eligibility. In addition to creating study documentation, they may provide oversight to junior staff members and students, in addition to items such as source documentation, PHI protection following HIPAA and Institutional guidelines, and reporting protocol deviations and adverse events.
3. In conjunction with the PI or Director, interprets and applies current research findings in the area of clinical specialty and reports findings in professional journals and local, state, and national conferences.
4. Identifies various stakeholders to ensure adequate design, implementation, and testing of study aims.
5. Prepares and submits multiple levels of research documentation (i.e. IRB, invoices, reports, grant applications, renewal reports (RPPR), and study forms).
6. Collects information to determine study feasibility. Makes recommendations to investigators and oversight organizations, as appropriate.
7. Creates and maintains REDCap Database and data entry forms, runs reports, and checks data quality. Develops plans to address data quality issues.
8. Maintains compliance with federal, state and accrediting agencies (sponsors), including maintaining any required documentation.
9. May conduct literature reviews and develop solutions for operational shortcomings of data procurement in protocol design.
10. Prepares for and leads team meetings. Disseminates information related to studies, trainings, and general research operations as needed. Assists colleagues in identifying inefficiencies and improving processes.
11. Arranges multidisciplinary evaluations.
12. Performs other duties as assigned.

Annual Salary Range : $60,835 - $80,000

Patient Populations Served Neonate: Birth - 1 year Toddler: 1 year and 1 day - 3 years Preschool: 3 years and 1 day - 5 years School: 5 years and 1 day - 12 years Adolescent: 12 years and 1 day - 18 years Young Adult: 18 years and 1 day - 28 years

Body Fluid Exposure Category 1: Typical job duties involve exposure to body fluids or tissues. Physical Requirements: Walking to locations on Campus, Carrying/Moving/Lifting objects up to 20 lbs.

Environmental Exposure: No adverse environmental conditions expected.

Disclaimer Please Note: The duties and responsibilities described are not a comprehensive list, and additional tasks may be assigned to the employee as necessitated by business demands. This does not constitute a contract of employment or otherwise limit UAB's employment-at-will rights at any time. Employees are expected to comply with all UAB policies and procedures during their employment.

Qualifications

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

• Human Subject and Pediatric research experience preferred.
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification preferred. PI is willing to support training activities and exam fees toward certification over the first year of employment.
• Provide supervision of CRC I and CRC II staff and undergraduate students on projects under the direction of the Core PI.
• Work with PI and Financial Officer on preparation of study budgets, ordering of research materials, and providing invoices and receipts to Department officials to maintain proper records.
• Problem-solving skills.
• Working knowledge of related scientific and clinical terminology.
• Familiarity with IRAP, UAB's online IRB system, or similar systems.
• Database development and management.
• Leadership skills.
• Presentation skills.
• Prioritization skills.
• Organizational skills.
• Written and verbal communication skills.
• Demonstrated expertise in clinical research operations according to GCP.
• Interpersonal skills to support staff and families from varied backgrounds.