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Requisition Number 17-0062
Post Date 9/1/2017
Title Regulatory Associate
Position Type Full Time
Work Hours 40 hpw
City Morgantown
State WV
Description Summary
Examines, evaluates, and investigates conformity with the regulatory aspects of industry and government sponsored clinical trials and investigator initiated clinical research. This includes securing Institutional Review Board (IRB) approval and maintaining all records pertaining to IRB approval and oversight. Performs various duties, such as research, analysis and auditing in support of project IRB submissions to assure compliance.

Duties & Responsibilities
1. Plans and writes materials required for IRB submissions.
2. Review submission-related documents from clinical research protocols to ensure consistency with institutional compliance guidelines.
3. Develops and prepares informed consent documents according to institutional guidelines.
4. Submits study protocol amendments to the IRB.
5. Assists with the submission of IND safety reports and adverse event reports to the IRB.
6. Tracks all IRB submissions and communicate with IRB administration regarding new submissions and approved protocols.
7. Monitors, evaluates and improves regulatory submission tracking/control systems.
8. Submits appropriate documents to close or suspend study protocols.
9. Submits and tracks regulatory documents in the clinical trials management system (CTMS) utilizing the work flow and processes
10. Assists in networking opportunities and continuing education.
11. Maintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility, and adheres to industry and government standards.
12. Assists and/or follows direction of management to determine the best course for customer service.
13. Communicates with investigators, coordinators, and sponsors by email, telephone or in-person.
14. Responds to questions regarding regulatory issues.
15. Gathers anecdotal and raw data, assesses situations or program information, consider options, propose resolutions, create reports and translates data to graphical media or code.
16. Assist with or complete forms for IRB submissions, etc.
17. Trains users regarding electronic IRB applications.
18. 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.
19. Adjusts, refers for and/or investigates complaints.
20. Testifies before auditors and administrators.

Supervisory/Lead Role
Position reports to the Clinical Research Services Manager, CTSI CT.
Physical Demands
Activities require manual skill to provide and/or alter services and/or products. Manual dexterity used in operating office equipment. Prolonged periods of sitting, and the ability to walk short distances is required. Use of elevators and/or stairs is routine. Activities are predominantly non-manual though some manual work not directly involved with altering or transporting of products may be included.

Work Environment
This position will work in a normal office setting. Fluctuations in heating/air conditioning temperatures occur with the change of seasons. Responsible to know and comply with all safety procedures.

Requirements Requisite Qualifications
Education and/or Experience
1. Bachelor’s degree in an allied health discipline or related field;
2. 2 or more years of experience in regulatory aspects of industry and government sponsored clinical trials including IRB application submissions;
3. Equivalent combination of education and experience.

Certifications, Licenses, Registrations
1.After a minimum of 2 years of employment, it will be expected that the incumbent obtain certification as a Research Professional through the Society Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP).

Skills, Knowledge, Abilities
1. Working knowledge of regulatory aspects of industry and government sponsored clinical trials including IRB regulations.
2. Skilled at problem solving.
3. Excellent teamwork skills.
4. Basic work processing skills and understanding and the ability to handle stress and work under pressure.
5. Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
6. Strong time management skills.
7. Computer proficiency, including Microsoft Office.
8. Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.
9. Ability to write reports, business correspondence, and procedure manuals.
10. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
11. Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
12. Ability to compute rate, ratio and percent and to draw and interpret bar graphs.
13. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
14. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
15. Ability to manage multiple projects and changing priorities is required.
16. Demonstrated ability to work effectively in both cross-functional teams and independently is required.
17. 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.

Behavioral Competencies
1. Technical skills – Strives to continuously build knowledge and skills; pursues training and development opportunities; assess strengths, weaknesses, and shares expertise with others.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

  • AA/EOE/Minorities/Females/Vet/Disability/E-Verify Compliant Employer.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
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