Associate Director of Clinical Research (Hybrid Opportunity)

The Division of Pulmonary, Allergy & Critical Care Medicine is seeking an Associate Director of Clinical Research to provide leadership and oversight of complex large or multiple small clinical research projects. Supervise multiple clinical research staff, leads, managers. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight. Mentor Clinical Research Managers.

The Division of Pulmonary, Allergy and Critical Care Medicine (PACCM) is comprised of a team of outstanding clinicians, scientists, and scholars dedicated to improving the lives of patients with serious lung disease. Our goal is to provide outstanding clinical and research training to the next generation of leaders in Pulmonary and Critical Care Medicine. We are committed to strong clinical investigations including the evaluation of new pharmacologic agents, which offer potentially promising therapeutic benefits, as well as outcome studies which characterize clinical parameters to effect positive changes in patient care.
 

This is a hybrid opportunity.

Core Duties:

• Select, develop, and evaluate personnel to ensure efficientoperations, including hiring, performance management, and relatedduties. Oversee staffing and overall resourcing for program(s) underpurview. Mentor Clinical Research Managers.

• Audit operations to ensure effective implementation of internalprocesses and quality program. Provide leadership in identifying andimplementing corrective actions/processes. Lead inspections oraudits.

• Oversee development of effective participant recruitment andretention activities. Oversee development of regulatory documents,including consent forms, for studies.

• Make strategic decisions regarding new and existing clinicalresearch projects that may impact resourcing, quality, safety and/orcompliance of program(s) under purview. Lead or chair committees or taskforces to address and resolve significant issues.

• Develop and/or implement research goals for a clinical trial(s)/therapeutic program in collaboration with multiple faculty members andinternal/external stakeholders.

• Oversee regulatory management of programs and troubleshootcomplex regulatory issues. Mentor and train managers and staff on how toresolve compliance issues and regulatory challenges acrossprograms/organizations.

• Provide oversight and guidance on compliance with local, federaland international regulations on clinical research conduct. Lead processand quality improvement initiatives to ensure efficiency inimplementation of new protocols.

• Manage and track research program financial status with regularreports to research leaders. Oversee development of appropriate studybudgets that meet the needs of the research program.

• Engage in high-level outreach and networking opportunities in aprogram leadership capacity, representing the research program to avariety of internal and external audiences.

• Analyze trends in recruitment across the portfolio, develop andmonitor use of standardized reporting of key metrics. Develop ideas andimplement improved processes and tools to ensure program success andcompliance.

• Contribute to analysis of data and preparation of manuscripts andscientific presentations.

Minimum Education:

Bachelor's degree in related field

Minimum Experience:

Five years of experience in clinical research, or an equivalentcombination of education and relevant experience. Master's degreepreferred.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills.

• Excellent diplomacy skills

• Proficiency in Microsoft Office and database applications, andEHRs (i.e., REDCap Cloud, EPIC).

• Experience with research protocols and regulatory or governingbodies, which include HIPAA and FDA regulations, Institutional ReviewBoard requirements, and Good Clinical Practices.

• Knowledge of medical terminology.

• Minimum of three years of demonstrated managerialexperience.

• Demonstrated disease knowledge / study design experience ofstudies under purview.

Certificates and Licenses Required

Society of Clinical Research Associates or Association of ClinicalResearch Professionals certification is preferred.