Research Protocol Specialist

Duties

• Participates with the Principal Investigator in the scientific design of research protocols and makes recommendation on methodology.
• Participates in staff development, in-service and professional continuing education programs.
• Evaluates research protocols for compliance with applicable regulations governing human subject's protection.
• Assures the proper documentation of project/study, giving particular attention to any protocol modifications.
• Coordinates with investigators and other designees to ensure Institutional Review Board (IRB) stipulations are appropriately addressed in a timely manner by providing expert knowledge and advice regarding regulatory requirements.
• Serves as a resource for and consultant to Principal Investigators, research coordinators, and other Research Review Service staff, as necessary.
  Requirements
  Conditions of employment
  
• Appointment may be subject to a suitability or fitness determination, as determined by a completed background investigation.
  
• This position is designated as moderate risk involving Public Trust. Appointment to this position is subject to a background investigation including a credit check to determine suitability for Federal employment and/or the position.
  
• This position has mandatory seasonal Influenza vaccination requirements and is subject to annual seasonal Influenza vaccinations unless otherwise exempted for medical or religious reasons (documentation of exemption must be provided upon hire).
  
• You may be authorized to Telework on a Situational basis.

Qualifications

Who May :

US Citizens

In order to qualify, you must meet the education and/or experience requirements described below. Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; student; social). You will receive credit for all qualifying experience, including volunteer experience. Your resume must clearly describe your relevant experience; if qualifying based on education, your transcripts will be required as part of your application. Additional information about transcripts is in this document.

Basic Requirement for

Research Protocol Specialist:

Degree:

Bachelor's or graduate (or higher level) degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program accredited by an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. (

Note:

You must attach a copy of your transcripts.)

In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below:

Specialized Experience:

One year of specialized experience which includes utilizing a wide range of scientific and biomedical concepts, principles and practices to perform the highly specialized tasks of developing and supporting proposed and active clinical research studies; interpreting research regulations and identifying potential threats to compliance with regulations and requirements in clinical settings; and communicating with physicians and other healthcare personnel in a professional capacity. This definition of specialized experience is typical of work performed at the next lower grade/level position in the federal service (GS-11).

Certified IRB Professional (CIP) credential preferred but not required.

Some federal jobs allow you to substitute your education for the required experience in order to qualify. For this job, you must meet the qualification requirement using experience alone--no substitution of education for experience is permitted.

Education

FOREIGN EDUCATION

If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: sites.ed.gov/international/recognition-of-foreign-qualifications/.

Additional information

• Male applicants born after December 31, 1959 must complete a Pre-Employment Certification Statement for Selective Service Registration.
  
• You will be required to provide proof of U.S. Citizenship.
  
• This position requires a 1 year probationary period during which the agency evaluates your fitness and whether your continued employment advances the public interest.

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