Clinical Operations Manager - Baltimore, United States - US National Institutes of Health

US National Institutes of Health
US National Institutes of Health
Verified Company
Baltimore, United States

1 week ago

Mark Lane

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Mark Lane

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Description

Duties:


  • Develop and implement infrastructure for supporting Intramural clinical research initiatives.
  • Manage or coordinate multiple initiatives pertaining to the development and execution of clinical research within the clinical program.
  • Perform oversight/management pertaining to the regulatory and procedural aspects of clinical site monitoring and performance evaluation.
  • Review protocols and informed consents and advises on regulatory requirements and compatibility with IRB guidelines/templates.
  • Serve as an expert resource with respect to protocol development, implementation, overseeing clinical program operations, and performance evaluation.
  • Serve on Institute, and transNIH committees pertaining to clinical research activities.
  • Participate in and represent the needs of investigators and leadership in protocol navigation, policy, regulatory affairs, operational committees, meetings or workgroups as well as in other NIH initiatives.
  • Provide general support, as needs arise, related to the mission of the Neuroimaging Research Branch (NRB) to coordinate, support, and supervise the development, implementation and conduct of intramural clinical research activities.

Requirements:


Conditions of Employment:


  • U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
  • Applicants must meet all qualification requirements by the closing date of this announcement.
  • Males born after December 31, 1959 must be registered with the Selective Service.
  • Position requires Education.

Qualifications:


  • You qualify if you meet the following qualification requirements:
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Basic Education Requirement:


In order to qualify for a Clinical Operations Manager, GS-601, position you must have successfully completed 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 the 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
-
Additional Specialized Experience:


In addition, in order to qualify for a Clinical Operations Manager, 0601, at the GS-13 level, 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: developing strategic plans and procedures to facilitate clinical research initiatives; conducting comprehensive reviews of research protocols and documentation to ensure adherence to ethical, legal, and regulatory standards; facilitating collaboration across multidisciplinary teams to ensure effective research operations and protocol compliance; and leading policy development initiatives to ensure research practices align with the latest regulatory standards and operational guidelines.


  • 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, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position

Education:


Additional information:


  • A oneyear trial/probationary period may be required upon selection/ placement.
  • 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.
  • Visit our Total Compensation page and this sample for a detailed look into the benefits, awards, leave, retirement, and other incentives employees may receive as part of a rewarding work environment.
  • At the supervisor's discretion, this position may offer work schedule flexibilities: telework (work from home on a regular basis or ad hoc basis but reports to the office at least once a week/two days a pay period), Maxiflex schedules, or Alternative work schedules.
  • Benefits
Review our benefits


How You Will Be Evaluated:

You will be evaluated for this job based on how well you meet the qualifications above.

You will be assessed on the following competencies (knowledge, skills, abilities, and other characteristics):

  • 1. Clinical Research Management
  • 2. Regulatory Oversight
  • 3. Multidisciplinary Collaboration
  • 4. Policy Development
  • Best Qualified for those who are superior in the evaluation criteria
  • Well Qualified for those who excel in the evaluation criteria
  • Quali
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