Dir Clinical Research - TMC Oncology

SUMMARY:

Oversees and coordinates clinical research program, planning, protocols, reporting, and activities. Evaluates clinical research studies and serves as liaison between physicians, investigators, funding agencies, research institutions, Food and Drug Administration, Office for Human Research Protections and TMC HealthCare.  Coordinates development and implementation of the established procedures to process applications for review, research protocols, clinical trials, and data analysis. Demonstrates competence in clinical research skills, problem solving, priority setting and resource allocation. Includes a broad spectrum of strategic, proactive, and capacity building activities designed to enable and enhance the competitiveness of research programs and proposals for extramural support.

ESSENTIAL FUNCTIONS

Develops, facilitates, implements, evaluates, performs, administers and oversees a wide variety of research programs or initiatives.

Establishes and maintains program metrics.

Establishes and maintains program policies and procedures.

Develops and implements research protocols from study start-up to closure, including the procedures, data collection and analysis, and all reporting activities.

Identifies funding opportunities. Provides guidance and coaching on the creation of research funding plans including the identification of funding opportunities through database searches, coordination with program officers, responding for information and general capture planning. Interacts with funding agencies and institutional research and leadership. Develops competitive research grant applications.

Builds and collaborates with a researcher team in the preparation of extramural proposals, including aligning proposals to solicitations, ensuring adherence to submission requirements, writing non-technical content (e.g., management plans), fit to solicitations and proposal management.

Prepares and provides guidance on Food and Drug Administration applications for the use or study of an investigational product.

Develops organizational plans to optimize research compliance, participant safety, and communicates trials to the community. Develops and ensures work processes, policies, and procedures are followed in accordance with state and federal regulations.

Develops and performs research billing, and reviews research-billing claims.

Performs quality improvement methods and training to optimize the program.

Primary 24/7 contact to receive adverse event reports and research inquiries (e.g. 24/7 consent contact).

Oversees Clinical Research Staff, operations of the program, and other study proposals at the organization.

Prepares study staff for recruitment/enrollment for various research projects.

Collaborates effectively with physicians, investigators, other staff members, Institutional Review Board, sponsors, and other stakeholders.

Organizes, maintain, and documents all project activities, data, and correspondence.

Assists other members by educating, providing resources, and consulting on difficult protocols or procedures. May change/modify procedures to accommodate project needs.

Identifies issues for IRB review and consideration.  Provides regulatory, historical, ethical and administrative input and guidance as required by circumstances. 

Responsible for compliance with ethical guidelines, federal regulations and state statutes for Human Subject Research.

Notifies TMC's senior management and regulatory officials as needed of issues of non-compliance, and informs the Compliance Officer and Chief Medical Officer and Senior Vice President of Medical Affairs of IRB concerns, issues, problems, and needs.

Notifies TMC's senior management and regulatory officials as needed of issues of participant serious adverse events, and informs Quality and Chief Medical Officer and Senior Vice President of Medical Affairs of safety concerns, issues, problems, and needs.

Communicates with investigators regarding status of approval, continuing review and re-approval processes; assists investigators and study coordinators in writing/revising protocols and consent forms.

Assists health care providers in their research and data analysis design, study management and evaluation, and publication of health care research.

Certifies to federal, corporate and/or private funding agencies that TMC HealthCare investigators have complied with regulatory, legal and ethical issues.

Maintains confidentiality and protects sensitive data at all times, including patient information, proprietary information and personnel information.

Develops and manages research budgets and monetary disbursements.

Participates in preparation of clinical research visits and conducts all clinical and laboratory assessments as delegated per protocol for various disciplines.

Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.

Serves as a Human Protections Administrator (HPA) to form and maintain a local Institutional Board for TMC HealthCare.

Identify protocol problems, inform investigators of problems, and assist in problem resolution efforts such as protocol revisions.

Interprets federal regulations, ethical principles, state law and institutional policies relating to involvement and protection of human subjects in research.

Subscribes to and upholds established standards of behavior.

Adheres to organizational and department-specific safety standards and guidelines.

Adheres to TMCH values of integrity, diversity, accountability, compassion, and teamwork.

Performs related duties as assigned.

MINIMUM QUALIFICATIONS

EDUCATION:  Master’s degree from a college or university specializing in law, biomedical sciences, ethics, public health, healthcare administration, or related field; or equivalent advanced learning attained through professional level experience required and competencies that results in adequate performance of the job.

EXPERIENCE:  Eight (8) years of related experience.

LICENSURE OR CERTIFICATION: None Required

KNOWLEDGE, SKILLS AND KNOWLEDGE:

• Current working knowledge of Good Clinical Practice (GCP), International Conference on Harmonization (ICH), federal, Human Subject Research Compliance Oversight Procedures issued by the Office for Protection from Research Risks (OPRR) under the National Institutes of Health (NIH).
• Ability to read, analyze and interpret scientific and technical journals and/or legal documents.
• Ability to respond to sensitive and/or confidential inquiries or complaints from regulatory agencies or members of the community; ability to make effective presentations or write articles and reports for publication that conform to prescribed style and format;
• Ability to effectively present information to senior management, physicians, public groups and/or boards of directors.
• Ability to work with concepts such as fractions, percentages, ratios and proportions, and to apply mathematical operations to solve or analyze job-related situations; ability to create financial forecasts and budgets.
• Ability to identify positive or negative variances from expected outcomes.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Ability to deal with nonverbal symbolism; ability to deal with a variety of abstract and concrete variables.
• Ability to perform critical thinking and analysis. 
• Ability to digest regulatory, industry, and other business guidance, and to communicate and advise necessary actions needed on behalf of the organization. 
• Ability to demonstrate effective use of computer software tools to assist in accomplishment of duties. (e.g,. IW/XRS, EDC, Excel, Word, Outlook, PowerPoint)
• Ability to manage a diverse and demanding workload.
• Ability to demonstrate scientific method.