Regulatory Manager - Rockefeller Neuroscience Institute

West Virginia University Research Corporation is currently accepting applications for a Regulatory Manager with the Rockefeller Neuroscience Institute (RNI).

Rockefeller Neuroscience Institute is the premier multidisciplinary institute for patient care, research, and teaching in West Virginia and the region. We celebrated the opening of our new Innovation Center on May 15, 2019. The RNI's flagship facilities are located on the Health Sciences campus in Morgantown, with more than 1,000 dedicated team members across five departments, patient care units, and research laboratories. Find out more about our outstanding works and contributions today at:

About the Opportunity

This position will function as the IRB liaison for the unit. Executes, maintains and tracks all IRB submissions. Identifies the requirements of various types and phases of clinical trials.

At WVU Research Corporation, we strongly believe in work-life balance and keeping time for things we love outside our work. WVU Research Corporation offers a comprehensive benefits package with a variety of options to suit your needs:
* 13 paid holidays ()
* PTO
* 403(b) retirement savings with a fully vested 3% employee contribution match, (Employees have the option of contributing an additional 1-3% of their earnings to the plan, which is also matched by the WVURC)
* A range of
* Dependent Education Scholarship
* WVU Perks
* And More!!

What you'll do:

Regulatory Compliance:

• Function as the IRB liaison for the unit. Executes, maintains and tracks all IRB submissions, including but not limited to initial reviews, amendments, continuing reviews and closures) following all applicable federal regulations
• Responsible for timely reporting of all IRB, FDA and other applicable agency reportable events (including but not limited to SAEs, deviations, etc.)
• Plans and writes materials (such as protocols, informed consent documents, promotional material etc.) for IRB submission.
• Review submission-related documents from clinical research protocols to ensure consistency with institutional compliance guidelines.
• Generates required regulatory documents for each study and obtain proper authorizations.
• Prepares and submits Investigational New Drug (IND) and Investigational Device Exemptions (IDE) applications to the FDA. Ensures timely submission of supplements and annual reports through the life cycle of the IND or IDE.
• Monitors, evaluates and improves regulatory submission tracking/control systems.
• Submits and tracks regulatory documents in the clinical trials management system (CTMS) utilizing the workflow and processes.
• Prepares and submits institutional and other regulatory reports.
• Works with cross-functional team to ensure that documents and reports materials produced are effective for the intended audience.
• Participates in the quality control of study documents and files.
• Assists in networking opportunities and continuing education.
• Maintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility, and adheres to industry and government FDA, National Institute of Health (NIH) standards.
• Assists in drafting and reviewing department SOP's.
• Works closely with Quality, Clinical Operations and other functional leads to assist with the development, design, and implementation of training materials for current and newly hired employees.
• Assists and/or follows direction of management to determine the best course for customer service.
• Communicates with investigators, coordinators, and sponsors by email, telephone or in-person.
• Gathers anecdotal and raw data, assesses situations or program information, consider options, propose resolutions, create reports and translates data to graphical media or code.
• Assist with or complete forms for IRB submissions, etc.
• Trains users regarding electronic IRB applications.
• Contacts investigators, coordinators, and sponsors to establish rapport, understanding and/or inform, as well as to facilitate use of the organization's programs, services, and/or products.
• Adjusts, refers for and/or investigates complaints.
• Testifies before auditors and administrators.

Protocol Compliance:

• Identifies the requirements of various types and phases of clinical trials, including objectives, sample sizes, and patient care needs.
• Identifies sources for and facilitates adherence to current regulations, guidance, and policies that affect research at the institutional, state, federal, and international levels.
• Promotes compliance with the varied processes and procedures required by different types of sponsors.
• Protects patient, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
• Participates in discussions regarding feasibility of protocol implementation based on knowledge of institutional capabilities and limitations, therapy, or population of interest.
• Ensures validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events.
• Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for experimental devices or drugs as indicated.

Clinical Trials-Related Communication:

• Ensures ongoing formal and informal communication regarding clinical trials with team members to include superb, frequent communication and periodic in-person meetings with the principal investigator to discuss the trial status, data and any relevant issue.
• Provides general clinical research as well as trial-specific information to research, clinical, and other organizational staff.
• Develops relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with and accrual to clinical trials.
• Participates in study initiation meetings.
• Advocates for the safety and care of clinical trial patients as well as for the promotion and integrity of the clinical trial.

Documentation:

• Serves as advisor with regard to regulations, institutional policies, and sponsor requirements governing source data and documentation.
• In an advisory role, helps to ensures that relevant data from the source document are abstracted and recorded in the clinical trial case report forms and that every data point can be verified within the source document.

Ethical Issues:

• Advocates for ethical care of clinical trial patients and the conduct of clinical trials in accordance with standards of nursing practice.
• Promotes ongoing compliance with key ethical concepts by the research team, including informed consent, documentation, and respect for persons, beneficence, and justice.
• Ensures that members of vulnerable populations enrolled in clinical trials are identified and that their rights are addressed.
• Identifies and follows institutional procedures to report any falsification of data or scientific misconduct.

• Bachelor's degree in an allied health discipline or related field; Or equivalent combination of education and experience.
• A minimum of two (2) years of experience:
  • Regulatory aspects of industry and government sponsored clinical trials including IRB application submissions.
  • Managerial experience or program oversight
• Strong inter-personal communication skills that exhibit creativity, leadership and listening skills.
• Strong working knowledge of regulatory aspects of industry and government sponsored clinical trials including IRB regulations.
• Excellent teamwork skills.
• Basic work processing skills and understanding and the ability to handle stress and work under pressure.
• Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
• Strong time management skills.
• Computer proficiency, including Microsoft Office.
  
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, 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.
• Ability to manage multiple projects and changing priorities is required.
• Demonstrated ability to work effectively in both cross-functional teams and independently is required.
• Must be able to read large volumes of printed material in a short period of time and be able to identify inconsistencies, incomplete and/or inaccurate information, provide corrections, and changes.
  
• Technical skills - Strives to continuously build knowledge and skills; pursues training and development opportunities; assess strengths, weaknesses, and shares expertise with others.
• 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; exercises discretion and sound judgment; is tactful and responsible for own actions. Adheres to work schedule and complies with leave management responsibilities.

After a minimum of two (2) years of employment, it will be expected that the incumbent obtain certification as a Research Professional through the Society Clinical Research Associates (SoCRA), the Association of Clinical Research Professionals (ACRP) or Regulatory Affairs Professional Society (RAPS)

The WVURC was created as a not-for-profit corporation in 1985 to support research (R1) at West Virginia University. We provide evaluation, development, patenting, management, and marketing services for inventions of the faculty, staff and students of the University.

The WVURC receives and administers funds awarded by external agencies for research and other activities and is responsible for helping protect intellectual property through patents, copyrights and licensing agreements for start-up companies based on University research.

Creating an inclusive, engaged, and dynamic environment is core to WVURC's mission. We welcome candidates who can contribute a range of ideas, approaches and experiences.

West Virginia University Research Corporation is proud to be an Equal Opportunity employer. We value diversity among its employees and invites applications from all qualified applicants regardless of race, ethnicity, color, religion, gender identity, sexual orientation, age, nationality, genetics, disability, or Veteran status.