Human Protections Administrator

Description HUMAN PROTECTIONS ADMINISTRATOR

Clinical Research Management, Inc. (CRM) is a Government Contractor specializing in infectious disease research in the U.S. and aboard. CRM provides GxP services, research personnel, and support services, contributing to the development of vaccines, drugs, and devices, to help prevent, diagnose, and treat human disease. CRM has an immediate need for a Human Protections Administrator in Frederick, Ohio.

RESPONSIBILITIES
1. Administer and facilitate office operations and services of the Office of Human Use and Ethics, ensuring compliance of the IRB with federal, state and institutional regulations for protecting humans who are subjects of research. Assist in the development and implementation of Institute and IRB policies responsive to changes in the field of medical ethics. Oversee part-time and volunteer staff of the Office.
2. Act as a professional member of the Office of Human Use and Ethics, review, offer guidance and assure compliance with federal regulations and institutional policy for all protocols for research involving human subjects. Offer support, expertise and assistance to the committee as needed to ensure appropriate review and disposition of protocols describing safety and effectiveness of new biological, pharmaceutical, and medical device products which are activities regulated by the Food and Drug Administration (FDA), Department of Defense, and HHS Office of Human Research Protections (OHRP).
3. Shall cooperate with Institute and Medical Quality Assurance Units to develop internal auditing mechanisms ensuring compliance with federal regulations and guidelines. Design, implement and oversee systems designed to effectively streamline the submission, initial review and continuing review processes. Develop communication methods for timely communications of IRB actions to scientists, staff and administrators throughout USAMRIID. 4. Design, develop and implement office operations and policy ensuring efficient workflow, office communications, assessments and effective prioritization of assignments. Oversee development and ongoing maintenance of methods of communicating with researchers and regulators.
5. Oversee the development, implementation and efficacy of computerized information resources, including the web site, to inform, educate and ultimately receive and process individual human use protocols for review and approval/archiving/reference.
6. Provide professional guidance and formal training in all aspects of IRB activity to all Clinical Investigators and all IRB members.
7. Serve as the Health Insurance Portability and Accountability Act (HIPAA) Privacy Officer who in turn will be responsible for developing and enforcing Policies and Procedures for assuring Protected Health Information privacy, confidentiality and security.
8. Serve as the administrator for the annual training of all USAMRIID personnel in HIPAA compliance and provides assistance to investigators and clinicians in preparing HIPAA authorizations for release of protected health information.
9. Responsible for educating the USAMRIID community regarding issues governing the protection of human subjects in research.
10. Ensure the necessary educational outreach is received by research investigators, HUC members and other relevant personnel maintain continuing knowledge of and comply with human subject protection requirements.
11. Address issues of research misconduct that may arise at USAMRIID.
12. Provide all job-related progress reports/technical reports as requested.
13. Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
14. Performs light duties and other related duties as required and assigned.

Requirements REQUIRED SKILLS / EXPERIENCE

1. Graduate or doctorate level education in bioethics, philosophy, nursing, or a related research or health profession and 3 years experience in a professional capacity ensuring institutional federal compliance or the equivalent combination of education and experience area strongly preferred. Additionally, the contractor must have advanced education in Philosophy or Bioethics or have sufficient experience in IRB activities to be able to independently plan and execute a human research protection [HRPP] IRB and PI education program.
2. Must have experience in the following: comprehensive knowledge and application of regulations, policies and directives for the protection of human subjects and the ethical grounding of these rules.
3. Shall have the knowledge of computerized information systems.
4. Thorough knowledge of federal regulations for the protection of human subjects and the ethical grounding of these rules preferred.
5. Willing to obtain an Investigational Review Board certification.
6. Shall perform travel when necessary to accomplish a given task and to maintain continuing education in human subject protections.
7. Required Knowledge, Skills and Abilities: knowledge of applicable highly complex scientific procedures and techniques relating to position.
8. Must be able to work independently following a brief period of specific technical training.
9. Must be a US Citizen to meet the requirements of the DoD Facility.

ATTRIBUTES

CRM currently offers the following benefits to full-time employees: • Paid vacation, sick and holiday leave. • Up to $3,000/year for Tuition Assistance. • Up to $500/year for Professional Development Assistance. • Health, Life & Disability Insurance. • 401k Retirement Plan with Employer Match. • Flexible Spending Accounts • Voluntary Benefits – Dental, Short-Term Disability & Supplemental Life Insurance. • Other Benefits.

Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under CRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.

CRM is an Affirmative Action-Equal Opportunity Employer
* Please submit only one resume per position.
** Contact will only be made if there is further interest.
*** All posted opportunities are full-time, unless otherwise stated.

**** All candidates can apply at www.clinicalrm.com under the career opportunities section by selecting the position of interest and then the “apply to this job” link at the bottom of the job posting.