WVU Research Corporation Medical Director/Principal Investigator in Morgantown, West Virginia
Position is part-time (29 hpw, or less) with a variable, intermittent work schedule.
The purpose of this position is to lead the central regulatory responsibilities and full medical responsibilities of the WVU Clinical and Pharmacologic Research Center (WVU CPRC). The Principal Investigator will delegate certain responsibilities but always retains the ultimate responsibility of all research conducted at WVU CPRC.
This position is responsible to oversee, plan, direct, and coordinate organizational activities including policy formulation, management of daily operations, and resource stewardship consistent with business objectives. It may oversee procurement, human resources, communications, finance, general operations, and/or office support. Provides operational leadership; requires creativity, and interpretive abilities to effectively resolve complex problems. Work effort has significant impact on personnel, budget and operations, producing major organizational, legal and financial results and/or liability.
Duties & Responsibilities
Responsibilities are managerial in nature, and performed under nominal supervision. Specific tasks include, but are not limited to:
- ln conference with the Director, Clinical Operations, and designees select studies to be conducted
- Approve and maintain standard operating procedures that are consistent with all regulatory and procedural requirements
- Take full medical and regulatory responsibility for each study by signing the FDA Form 1572 and all the related regulatory documents
- Maintain dispensing license and controlled substance registration for the operation of WVU CPRC
- Oversee and assure full compliance on drug accountability of formulations used in the conduct of clinical trials from receipt of the drug from the sponsor organization to storage of retention samples.
- Provide the responsibility and control of dispensing of all drugs required for study conduct
- Oversee physician sub-investigators with respect to scheduling, training and competency assessments.
- Personally conduct physical examinations, evaluate ECG's, evaluate blood chemistry test results, drug screens, HIV test results, and hepatitis test results for all research subjects or maintain responsibility if delegated to sub-investigators
- Provide counseling to subjects regarding test results according to applicable state and federal laws
- Maintain an environment of subject safety and maintain an ongoing assessment of the safety profile of all studies
- Review and execute treatment of all adverse experiences. Provide treatment, follow-up and reporting of adverse experiences according to the protocol and regulatory requirements
- Provide "on-call" coverage of studies scheduled at WVU CPRC. Oversee on-call duties of physician sub-investigators (on-call means reporting to the unit and/or hospital to examine subjects and treat adverse experiences)
- Comply with all regulatory, sponsor, and WVU Research Corporation guidelines for conducting clinical research and handling adverse experiences
- Interact with appropriate FDA officials and sponsor representatives concerning study conduct, safety, and other study related issues as requested
- Provide medical and scientific input in clinical research programs including review of preclinical and/or clinical data, medical supervision of project teams, development of study protocols, CRFs, clinical study reports, serious and non-serious adverse event treatment, evaluation, and reporting, etc. Execute medical approval of CRFs and clinical study reports
- Make judgments and execute approval in conference with sponsors regarding study related medical/safety issues and resolution of study protocol and subject eligibility issues
- Review all adverse experiences. Provides treatment and medical surveillance of Serious Adverse Events (SAE), including after-hours treatment of medical emergencies, follow-up, and reporting
- Provide medical responsibility, review, and editing of clinical study summary reports. Review and approve clinical data, tables, and codes for medical consistency, interpretation and coherence
- Interpret laboratory abnormalities or reference ranges, including panic lab values with appropriate clinical follow ups.
- Serves as medical liaison to institutional Review Board(s)
- Providing the IRB with all the requested documents subject to their reviews.
- Oversees pertinent communications with IRB Boards with respect to ongoing reviews, subject safety and satisfaction, FDA and other regulatory site visits, clinical holds, and serious adverse events.
- Ensure the proper and timely processing od study data
- Provide support and engagement to site audits by regulatory agencies (i.e., FDA, EMA, etc.) as well as sponsors.
- Ensures complete adherence to protocol requirements, subject safety and data integrity of clinical trials conducted within the framework of IHC/E6 Guidance document.
- Follows and ensures the enforcement of federal, state, and University policies and procedures in design and execution of clinical research
- Takes responsibility of ensuring training of clinical research staff, including in-servicing of project related materials on various study protocols
- Assures appropriate study and regulatory training and competency requirements are met with respect to delegated roles and responsibilities (Delegation of Authority/ Delegation of Responsibility)
- Provide medical and scientific development of clinical research programs including review of pre-clinical and/or clinical data, medical supervision of project teams, development of study protocols and CRFs
- Establish and maintain a network of medical/scientific consultants, etc.
- Execute a variety of team quality improvement efforts as necessary
This position reports to the Director Clinical Operations, Associate Vice President of Clinical Research Operations and Institutional Advancement. This position will direct and coordinate operational function(s) under general guidance of the Director Clinical Operations. Personnel supervision and work coordination of staff are required. In addition, general sharing of knowledge and team participation is expected in the role. Program, project or activity lead responsibilities will occur in this position.
This position requires standing and bending in the assessment and treatment of patients; requires manual dexterity used in drawing blood and processing the samples; prolonged periods of sitting and the ability to walk short distances. Work activities may require the use of elevators and/or stairs. Activities are predominantly non-manual though some manual work may be included.
Work is performed in a normal clinic/hospital setting and a processing lab. Exposure to diseases, body fluids, chemical and biologic hazards is possible. Incumbent is responsible to know and comply with all safety procedures. The following items have been determined as possible job exposures of this position requiring WVU EHS medical monitoring:
- Contact with Human Blood or Other Potentially Infectious Material (OPIM)- includes human body fluids, other than feces, urine, tears and sweat.
- Patient Contact- having contact with a patient, or with potentially contaminated items, including (but not limited to) blood and/or body fluids.
Education and/or Experience
- Doctorate in medicine;
- Experience in clinical evaluation of patients, research data collection, and computer systems
- 2 – 5 years of supervisory experience in clinical research or drug safety is required.
Certifications, Licenses, Registrations
- Must have a valid and unrestricted medical license, and be a registered dispensing physician (Licensed in WV)
- Must maintain an unrestricted DEA registration
- Board certification from an ABMS board with maintenance of certification
Skills, Knowledge, Abilities
- nderstanding and application of principles, concepts, practices and standards in the CRO industry.
- Ability to work concurrently on several projects, each with specific requirements that may differ from project to project; excellent time-management skills and decision-making skills.
- Ability to handle a high level of detail.
- Ability to interact sensitively, effectively and professionally with persons from diverse cultural, socioeconomic, educational, racial, ethnic and professional backgrounds and persons of all ages and lifestyle preferences.
- Ability to establish and maintain effective relationships and deal tactfully with departments, organizational units, related programs, and external agencies and individuals.
- Ability to work as part of a team and independently, exercising judgment and professionalism.
- Maintains skills in, or knowledge of, professional principles, legal and/or reporting requirements affecting area of responsibility.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Skilled at writing correspondence and preparing reports.
- Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
- Ability to compute rate, ratio and percent and to draw and interpret bar graphs.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
- Knowledge of the mission, goals, and policies of the program.
- Familiar with general computer applications including: Microsoft Office Programs and Internet search engines.
- Technical skills – Strives to continuously build knowledge and skills; pursues training and development opportunities; assess strengths, weaknesses, and shares expertise with others. Recording of data will require precision.
- Problem solving – Gathers and analyzes information, identifies problems, develops alternatives, uses reason even when dealing with emotional topics and works well in groups and resolves matters timely.
- Internal & External Customer Service – Manages difficult or emotional matters with objectivity and openness; responds promptly to needs and requests for service and assistance; meets commitments and dates, notifies others if change occurs; provides, solicits and applies feedback; and builds goodwill through balanced contributions, positive approach, respect and support of others.
- Communications – Demonstrates group presentation skills, participates in meetings, listens and gets clarification, is responsive and speaks clearly and persuasively in positive and negative situations. Writes and edits clearly and informatively, varies style to meet needs, presents numerical data effectively, and able to read and interpret written information.
- Organizational Support – Aligns work and develops strategies to meet organizational goals; seeks to improve and promote quality; demonstrates accuracy and thoroughness; and upholds organizational expectations and values.
- Self-Management – Responds to management direction; resourcefully adapts to changes in work environment and circumstances; responds well under pressure and manages competing demands; takes calculated risks, asks for and offers help when needed; exercise discretion and sound judgment; is tactful and responsible for own actions. Adheres to work schedule and complies with leave management responsibilities.
Requisition Number: 16-0066
Title: Medical Director/Principal Investigator
Post Date: 5/20/2016