Clinical Research Study Operations Manager
Summary
Join one of the 24 Institutes and Centers within the NIH that awards extramural grants! Extramural grants account for approximately 80 percent of NIH's budget and are awarded to investigators at more than 2,500 universities, medical schools, and other research organizations around the world.
Learn more about this agency
Duties
Help
- Protocol development and adherence, including initiating and implementing overall study protocol.
- Initiating and maintaining overall study operations manual, including soliciting and reviewing written operating procedures.
- Ensuring compliance with regulations and requirements, including writing and updating consent documents as required.
- Ensuring adherence to the protocols by using study oversight authority to inspect or review adherence to outlined policies and procedures.
Requirements
Help
Conditions of employment
- U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
- Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
- Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
- Males born after December 31, 1959 must be registered with the Selective Service.
- The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.
- The NIH maintains a tobacco free work environment and campus.
- Must be able to perform the essential duties of the position, with or without reasonable accommodation.
- Based on your appointment, a one or two-year trial/probationary period may be required. A decision regarding your continued employment with NIH will be made as you near the end of this period.
- This position requires education.
Qualifications
To qualify at the GS-13 grade level, if you meet the following qualification requirements:
A. Completion of a Bachelor's degree, or graduate/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 this position? (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained).
AND
B. You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: responsible for the scientific operations of research program studies, leading scientific research studies, executing the day-to-day operations of clinical research, and monitoring the safety of human subjects for a research organization.
You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay.
Do not copy and paste the duties or specialized experience from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.
We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer.
Preview application questionnaire before you apply: [click to reveal website link]
Education
This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.
Additional information
- If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. This information is required annually. For information, visit the NIH Ethics website: [click to reveal website link].
- At one of the identified vacancies, This position is designated as a "non-emergency/teleworker" position and the selected candidate will be considered a "non-emergency/teleworker" employee. In the event of a closure, you must be available to telework or request leave.
- At one of the identified vacancies, This position is designated as an "emergency essential" position and the selected candidate will be considered an "emergency essential" employee and will be required to be available, ready, willing, and able to report for duty under all circumstances (e.g., inclement weather, government closings and holidays, lapses in appropriations, non-emergency and emergency situations) for operation 24 hours a day and 365 days per year coverage.
- Based on your appointment, a one or two-year trial/probationary period may be required. A decision regarding your continued employment with NIH will be made as you near the end of this period.
- At the supervisor's discretion, this position may offer work schedule flexibilities: telework compressed schedules, flexible schedules.
- A newly appointed or reappointed employee may receive service credit for prior work experience or active-duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
- A newly appointed or reappointed individual may receive a recruitment incentive. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
- PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration.
- Visit Help Applying for helpful information on the application process.
- If you believe you have a disability (i.e., physical or mental), covered by the Rehabilitation Act of 1973 as amended that would interfere with completing the USA Hire Competency Based Assessments, you will be granted the opportunity to request a RA in your online application. Requests for RA for the USA Hire Competency Based Assessments and appropriate supporting documentation for RA must be received prior to starting the USA Hire Competency Based Assessments. Decisions on requests for RA are made on a case-by-case basis. To determine if you need a RA, please review the Procedures for Requesting a Reasonable Accommodation for Online Assessments here: Reasonable Accommodation Information.
- Veterans' Preference only applies to Schedule A (disability appointment), HHS Reemployment Priority List (RPL) Eligibles, HHS Priority Reemployment List (PRL) Eligibles, and Veterans Recruitment Appointments (if applicable).
Expand Hide additional information
Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.
Benefits
Help
Review our benefits