Job Description

Essential Duties:

• Manages and monitors policies, practices and procedures of clinical research staff responsible for the implementation, management (including protocol updates / amendments), and quality conduct of clinical trials according to study protocols and Good Clinical Practice guidelines.
• Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical research staff. Assigns and manages workload and provides estimates for individual project staffing needs using the Staffing Acuity Tool. Tracks data and metrics to determine appropriate personnel resource allocation based on study parameters.
• Serves as a subject matter expert on protocol management and study subject recruitment. Provides support and guidance to the study team to develop and maintain study specific materials (e.g., tracking logs, templates, monitoring tools, source documents, study binders, process manuals).
• Collaborates with CTO Clinical Trials Project Manager and Principal Investigator (PI) on assessment and operational implementation of highly complex trials clinical research protocols within Oncology Disease Group, including feasibility, identifying accrual targets, resolving potential discrepancies and/or barriers to enrollment prior to study activation and patient enrollment process. Serves as a liaison to the study sponsor, regulatory agencies, investigators, and clinical teams.
• Ensures infrastructure to conduct clinical trials by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies and regulations while ensuring participant safety. Includes assigning research support staff.
• Manages oversight of protocol conduct and ensures that research site personnel and investigators, are conducting the study according to the protocols and Good Clinical Practice guidelines. Stays abreast of federal and state regulations and local policies. Maintains a high degree of knowledge on these requirements and follows directives that may be required to ensure University compliance with congruency review and reporting requirements.
• Develops, implements, and champions internal practices that ensure compliance with federal requirements.
• Serves as a critical resource before and during interim monitoring visits, internal audits and external audits/inspections. Works with study monitors to ensure compliance with study requirements. Analyzes and interprets reports/findings from retro/prospective audits with investigators and advises and monitors appropriate action plan. Responsible for contributing to formal responses to audit and inspection report findings that relate to clinical operations findings.
• Contributes to the review and refinement of CTO standard operating procedures (SOPs) and assists with SOP training.
• Coordinates with Clinical Trials Project Manager to liaise between clinical and non-clinical related departments to resolve congruency issues in a timely manner for protocols/projects within their assigned Oncology Disease Group.
• Coordinates, oversees and participates in meetings including but not limited to Pre-study Visits, Site Initiation Visits, Monitoring.
• Other duties as assigned.

Required Education and Experience:

Bachelor’s degree in a health-related discipline, or other related field and a minimum of five(5) years of experience in clinical trials research or the equivalent combination of education or experience.

Required Skill/Ability 1:

Communication, leadership and team building skills: evidence of this should include resource management, effective problem solving, conflict resolution, motivating others as individuals and as groups, and planning, organizing, and directing the activities of others

Required Skill/Ability 2:

Ability to ensure appropriate infrastructure by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies, and regulation while ensuring participant safety.

Required Skill/Ability 3:

Strong knowledge of Good Clinical Practice guidelines. Ability to interpret federal, state, University and sponsor policies and regulations. Ability to interpret complex oncology clinical trial protocols and federal, state, local guidelines.

Required Skill/Ability 4:

Ability to provide proactive, flexible, and customer service focused advice; work effectively with others; and demonstrate ethics and integrity in a professional manner, sensitivity to confidentiality, and a commitment to protecting research participants.

Required Skill/Ability 5:

Ability to manage several projects concurrently, while balancing competing priorities and deadlines. Extreme flexibility in work focus; ability to switch among several different projects without any adverse effects. Ability to report on the status of project deliverables and draft and submit project updates to team and study sponsor.

• Preferred Education, Experience and Skills: Experience supervising staff. Experience with oncology clinical trials strongly preferred.
• Preferred Licenses or Certifications:
• ACRP/SOCRA (or equivalent) certification preferred. Willingness to obtain within one year.

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