Director of Research

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 compliance with applicable PPGC, PPFA, TDSHS, state of Texas, and U.S. policies, procedures, regulations, and laws related to human subjects research.

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.

Ensures complete confidentiality of research subjects including proper and prompt transfers, purging and storage of records.

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 interpersonal skills that will enable the candidate to work effectively in a collaborative team 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 general business periodicals, professional journals, technical procedures, research protocols, or governmental regulations.

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, research protocols, or governmental regulations.

Ability to write reports, business correspondence, and procedure manuals.

Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.

Ability to apply concepts of basic accounting such as invoicing, budget creation.

Reasoning Ability

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

Ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills

MS Word

MS Excel (Verified training documentation required)

Data Entry experience

Experience with Web Based CRFs (provide list of CRFs used)

Certificates, Licenses, Registrations

IATA Training Certificate

CITI Training: GCP, HSP, RCP modules required

Other Qualifications

Other Skills and Abilities

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to walk; sit; use hands to finger, handle, or feel; reach with

hands and arms and climb or balance. The employee is occasionally required to stand and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is occasionally exposed to outdoor weather. The noise level in the work environment is usually quiet.

Duties and responsibilities may be added, deleted or changed at any time at the discretion of management, formally or informally, either verbally or in writing.