Description

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

1. Provides a lead role in protocol screening and participant eligibility determination working alongside other team members to ensure compliance.

2. 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.

3. Responsible for conducting all study activities in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP).

4. Under the oversight of the Investigator and clinical research administrator, develops protocols, identifies efficiencies, and improves processes. Arrange multidisciplinary evaluations.

5. Maintains compliance with federal, state, and accrediting agencies (sponsors). Maintains any required documentation.

6. Manages site supplies as needed.

7. Maintains compliance with federal, state, and accrediting agencies (sponsors).

8. Maintains any required documentation.

9. Serves as a mentor to junior staff, including student assistants.

10. Performs other duties as assigned.

Annual Salary Range: $60,835 - $98,855

Qualifications

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.

UAB is an Equal Opportunity/Affirmative Action Employer committed to fostering a diverse, equitable, and family-friendly environment in which all faculty and staff can excel and achieve work/life balance irrespective of race, national origin, age, genetic or family medical history, gender, faith, gender identity and expression as well as sexual orientation. UAB also encourages applications from individuals with disabilities and veterans.

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