Principal Duties and Essential Functions

Manages day-to-day operations and is responsible for administrative aspects related to the Center in collaboration with faculty directors

Responsible for clinical trial processes and provides support to the clinical research team, and provides escalation to the Faculty Director when appropriate.

Works closely with PIs and study staff to assess feasibility of undertaking new projects or proposed protocols

Facilitates a protocol review committee

Establishes, develops and maintains partnerships with industry sponsors, other hospital collaborators and clinical trials network professionals as appropriate.

Maintains collaborative, team relationships with peers and colleagues to effectively contribute to Centers goals, and to help foster a positive work environment; may serve on Research and Hospital-wide committees related to clinical research and/or process improvement, if necessary or desired.

Is responsible for the overall supervision of clinical research staff including hiring, training, performance reviews and termination.

Is responsible for accurate and timely submission of IRB documents, data submission to the Clinical Trial Management System (CTMS) and data collection requirements for study sponsors.

Develops and monitors budgets, including standardized processes for budget development and budget workbook preparation and charge code identification.

Serves as primary contact for study monitor and on-site audits. Is responsible for ensuring appropriate preparation of materials for these activities.

Ensures compliance with all hospital, local, state, federal and sponsor guidelines and regulations that govern clinical research. Liaises with Compliance Officer and Research Administration to uphold regulations and report non-compliance. Works effectively to create and fulfill corrective action plans as necessary.

Works closely and communicates continuously with clinical research team and providers to steward effective recruitment, enrollment and retention processes.

Ensures investigational drugs are handled appropriately and curates a positive working relationship with the Investigational Drug Service.

Conducts regular team meetings, 1:1 staff meetings, and monthly meetings with the Institute leadership to review status of clinical trials, assess workloads, report on budget, and flag areas for discussion or decision-making

Ensures completion of each study on time and on budget and supervises the curating and logging of all study monitor and audit follow-up reports

Works collaboratively with Research Administration to facilitate budgetary discussions related to center funding, staffing, and financial projections.

Promotes a responsive and customer-oriented team in the center

Performs other similar and related duties as required or directed.

Job Knowledge and Skills

Strong interpersonal and management skills to interact with academic faculty, clinicians, and staff

Ability to manage and adhere to clinical research protocols, principles, and procedures

Ability to develop and monitor clinical trials budgets

Ability to engage in budget negotiation, financial auditing

Understanding of clinical research methods such as screening, interviewing, reviewing medical records, case report forms, etc.

Must possess strong planning, problem-solving, analytical, organizational, project management skills

Outstanding oral/written communication skills

Capacity to adaptively manage relationships with a variety of individuals in differing roles

Ability to anticipate programmatic needs and flag project risks to faculty leadership

Ability to delegate to others by setting priorities for completing multiple tasks

Proficient with the Microsoft Office Suite (Excel, PowerPoint, and Word) and Adobe Acrobat; familiarity with Box, Microsoft Teams, and Sharepoint a plus

Ability to effectively handle multiple competing deadlines and shifting priorities

Keen analytical skills; ability to identify, gather, manage, and synthesize relevant information to support data-driven decisions

Ability to have discretion with sensitive information, including PHI and other confidential information complying with institutional data privacy policies and guidelines

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com ( actalentaccommodation@actalentservices.com) for other accommodation options.