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HUMAN SUBJECT PROTECTIONS DIRECTOR-HOSPITAL

READING, PA
Responsibilities:

The Director of Human Subject Protections is knowledgeable of federal, state, local and institutional regulations enabling coordination of and responsibility for all Institutional Review Board functions to assure protection of human research participants.  The Director of Human Subject Protections is responsible to:

Establish and utilize IRB resource library.
Obtain and maintain Federalwide Assurance and IRB Registration with the Office of Human Research Protections at the U.S. Department of Health and Human Services.
Establish auditing procedure for informed consent process.
Participate in the review and disposition of matters of actual or potential non-compliance.
Perform expedited review in compliance with applicable regulations and policies. Requests consultant review of proposed or approved studies if
required.
Establish and implement a continuing quality assurance program.
Develop basic guidelines and information for new members and principal investigators.
Develop a continuing education program for committee members and principal investigators.
Develop, maintains and administers standard operating procedures (SOP's) for all aspects and functions of the IRB to assure compliance with pertinent regulations.
Perform expedited review in compliance with applicable regulations and policies.
Request consultant review of proposed or approved studies if required.
Act as resource for federal, state, local and institutional regulations pertaining to human research activities.
Maintain current knowledge of federal, state and local laws, regulations and guidelines governing human subject research.
Interpret and apply federal, state and local regulations, policies and procedures related to research involving human participants.
Attend educational and professional seminars as dictated by relevant certification standards.
Act as a liaison with federal and state agencies on human research issues.
Serve as the Human Protections Administrator on the Federalwide Assurance (FWA).
Provide advice, guidance and problem resolution to research investigators and support personnel in the application of relevant federal, state and local regulations and guidelines.
Participate in review of request for determination of Exempt from IRB oversight.
Attend monthly IRB meetings.
Generate detailed minutes adhering to federal criteria.
Create correspondence in compliance with the dictates of the committee.
Administer processing of all IRB documents.
Establishes agenda.
Conduct primary review of all items submitted for review by the committee.
Administer receipt, assignment, processing, review, tracking and file maintenance for all submitted information related to human research.
 


EDUCATION REQUIREMENTS

Master’s Degree

EXPERIENCE

2+ years related experience

CERTIFICATION AND LICENSURE REQUIREMENTS

Certified IRB Professional within 2 years of hire

REQUIRED SKILLS

Excellent Communications Skills
Excellent Interpersonal Skills
General Clerical Skills
Microsoft Excel, Word, PowerPoint & Outlook
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 
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