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Director of Research
4 months ago
Summary
Responsible for management of research department.. Oversees the day-to-day operations of clinical research activities for all studies, including ensuring full compliance with study protocols and policies, and regulations. Coordinates with health center management to initiate new studies, and ensure that implementation serves the strategic, tactical and financial goals of the Research Department, the health centers, and the affiliate overall. Serves as liaison to study sponsors.
Essential Functions
Manages PPGC research program.
Coordinates all activities and agreements, including proper IRB submissions and approvals, between PPGC, IRB, PPFA, educational institutions, pharmaceutical companies, CROs, commercial laboratories, affiliate legal counsel, etc., on all research studies conducted at PPGC.
Organizes all vendor activities including stipend management system, courier services, and dry ice (not all inclusive).
Functions as the Research Representative at PPGC events as needed.
Ensures that the research department supplies are maintained at adequate levels. Has authorization to order supplies as needed to fulfill this requirement.
Developments annual budget and revenue goals for Research Department.
Creates study-specific budgets that ensure compliance with Fair Market Value stipulations and IRS regulations for non-profit entities. Reports monthly HC allocations, Research Accounts payable/receivable, HC Research-RVUs, Stipends and department revenue to PPGC Fiscal.
Effectively manages the research departments budget in achieving net revenue goals, includes monthly revenue reporting, AR account reconciliation, invoicing to sponsors, check requests, etc.
Coordinates, trains, communicates with Directors of Operations, Patient Care managers and clinic staff to achieve optimum Health Center participation in Health Center integrated research.
Manages and coordinates CITI training in compliance with PPFA SOPs/Manual for Research for all HC staff including new hires.
Coordinates advertising and marketing to promote the PPGC Research Department to Industry Sponsors and other affiliated agencies, or to promote specific studies to the community in collaboration with the Research Recruiter/Trainer and PPGC Communications and Marketing Department.
Ensures all medical records, source documents, case report forms and other research and clinical documents are managed and maintained according to all applicable policies, procedures, regulations, and laws with specific focus on confidentiality, privacy and HIPAA.
Ensures compliance with PPGCs diversity, equity and inclusion policies in hiring, firing, transferring and promoting employees within the Research Department.
Ensures Research staff is adequately trained on relevant regulations/guidelines such as IATA, Protection of Human Subjects, PPFA SOPs, Good Clinical Practices, and protocol-specific information, and ensures that such documentation is maintained centrally and in study-specific files for continuity of communication with regulatory bodies.
Coordinate and communicate with Principal Investigator(s) regarding the feasibility of new studies, status of existing studies, and requests for audits/monitoring visits.
Collaborates with Associate Medical Director for Research to develop and implement investigator-initiated research studies.
Supervisory Responsibilities
**Supervises the Research Department team, including**: research coordinator(s), research clinician, research assistant(s), research recruiter/trainer, administrative assistant and research interns (paid and unpaid). Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include planning, assigning and directing work, appraising performance, rewarding and coaching employees, addressing complaints and resolving problems.
Competencies
**Core Competencies**: Computer Skills, Customer Service, Dependability, Diversity, Ethics, Initiative, Interpersonal Skills, Oral Communications, Organizational Support, Professionalism, Quality, Safety & Security, Teamwork, Written Communications
**Additional Competencies**: Analytical, Business Acumen, Conflict Management, Delegation, Innovation, Judgment/Decision Making Leadership, Managing People, Planning/Organizing, Problem Solving, Project Management, Technical Skills. Attendance/Punctuality
**Qualifications**:
Two to four years of experience in a management or research position preferably in healthcare or clinical research setting, preferably in a cross-collaborative, matrix environment.
Strong written and oral communication skills.
Ability to work in multi-functional team environment.
Experience with research budgets, research invoicing, and account reconciliation.
Education and/or Experience
Requires Bachelor's degree from four-year College or university.
Language Skills
Bilingual English/Spanish Preferred (must have documentation of proficiency)
Ability to read, analyze, and interpret genera
