MGR Clinical Trials Office

Minimum Education
Bachelor's Degree healthcare, scientific, business administration, finance or related field (Required)

Minimum Work Experience
7 years experience in research administration, health related field, accounting or business which includes clinical research experience (Required)

Required Skills/Knowledge
Strong project management, facilitative leadership, detail orientation, organizational, customer service, and oral written communication skills required
Supervisory experience is required
Strong knowledge of clinical process, medical terminology, and the clinical research lifecycle required
Proficient working knowledge of Microsoft Office Suite including Excel and multiple IT systems

Required Licenses and Certifications
Certified in Research Administration (CRA) or Healthcare Research Compliance (CHRC) within 5 years (Required)

Functional Accountabilities
Management and Operations

• Provides direct oversight of the Clinical Trials Office

• Development of short and long terms goals and objects for the team that align with Grants and Contracts Finance and institutional goals and regulatory requirements for research.

• Defines qualifications and performance expectations for staff positions based upon departmental goals and team goals.

• Conducts performance conversations with direct reports to discuss progress towards goals, performance of responsibilities, provides coaching, mentoring, and counseling.

• Applies problem solving, team building, and decision-making methods in daily operations.

• Implement performance improvement strategies to ensure performance metrics for accountability are consistently met.

• Participates in Strategic planning and development of efficient infrastructure for clinical research, clinical research revenue cycle and billing compliance program.

• Collaboratively identifies, establishes, evaluates, and maintains a comprehensive and strategic quality improvement program for pre and post award clinical research financial standards and practices.

• Facilitates the development of policies, standard operating procedures and job aides, reviews annually and updates accordingly.

• Works collaboratively and develops productive working relationships with Investigators, key study personnel, and applicable internal (IRB, Business Office, Grants and Contracts, Grants Accounting, Clinical Departments, Investigational Pharmacy) and external entities (Sponsors, External Collaborators) to accomplish departmental and team goals.

• Promotes superior customer service to effectively meet the needs of internal and external customers.

• Actively and collaboratively manages team members studies to ensure research billing compliance through the continuum of the study, crossing departmental boundaries within CNH to include Revenue Cycle, Clinical Departments and others as needed.

• Provides direct oversight for staff conducting Coverage Analysis to ensure billing compliance, clinical trial determination to ensure compliance with federal policies and guidelines.

• Provides authoritative guidance on Coverage Analysis and budget development as needed.

• Provides oversight for OnCore Clinical Research Management system operations and use.

Training/Education

• Create and deliver training and orientation for Clinical Research Administration including Billing Compliance, and other components of the administrative process to faculty and staff including research program managers and research coordinators.

• Recommends and develops, with input of GCAF Directors and Business Managers training for new hires and continuing learning for GCAF.

Reporting

• Reports non-compliance to Vice President of Research Administration and Finance. Develops reports and materials as needed for compliance committees.

• Develops monitoring reports to assure metrics are met across multiple areas.

• Analyzes data and recommends appropriate actions to address issues

Organizational Accountabilities
Organizational Accountabilities (Staff)
Organizational Commitment/Identification
Teamwork/Communication
Performance Improvement/Problem-solving
Cost Management/Financial Responsibility
Safety