Clarification from the agency

You must be a current or former federal employee eligible to apply under merit promotion procedures or otherwise be eligible as a status applicant (e.g., Veterans Employment Opportunity Act) OR be an individual who is eligible through an OPM interchange agreement or for a non-competitive appointment. This job is also open to USPHS Commissioned Corps Officers and Call-To-Active Duty (CAD) Candidates.

• Serve as a scientific resource on research teams collaborating with the Investigator, Protocol Coordinator and other team members to plan, develop and implement research protocols.
• Assist with the preparation of Manuals of Operation and other study documents such as recruitment brochures, web site content, etc. monitor and review adverse events files and reports and submitting timely and accurate reports on adverse events in accordance with NIH policy; and preparing evaluation reports and developing recommendations.
• Develop and maintain standard operating procedures for adverse event data collection, processing and reporting systems; collaborate with other staff to evaluate the adequacy of Data and Safety Monitoring Plans and provide recommendations for improvement and compliance.
• Monitor the regulatory and procedural aspects of clinical site monitoring and performance evaluation and prepare reports and documents for review by the Data and Safety Monitoring Board.
• Develop background materials for site visits, prepare site visit reports, and identify scientific and administrative issues requiring special attention; review and analyze summary reports of monitoring site visit findings and recommend consistent
  sanctions to be adhered to if institutions are not in compliance.
• Develop training materials and conduct training sessions for clinical trials specialists and clinical site coordinators; communicate effectively with staff at all levels involved in the conduct of clinical studies within NIH; conduct literature searched for content background for protocols; assist in preparing articles for publication; and prepare scientific and clinical research material to present at local, regional and national meetings.

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.
• Position has an education requirement. Please submit transcripts.

Qualifications

Basic Qualifications
In order to qualify for a Clinical Trials Specialist, GS-0601, 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 (https://ope.ed.gov/accreditation) at the time the degree was obtained).

Additional Qualifications
GS-12:
In addition, to qualify for a Clinical Trials Specialist position at the GS-12 level you must demonstrate at least one year of specialized experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: (1) Preparing comprehensive reports on the progress of clinical trials for review by senior leadership; (2) Reviewing clinical trial protocols for completeness and adherence to standards; (3) Compiling clinical research information for use in presentations; (4) Reviewing consent forms to ensure special considerations are met; and (5) Monitoring research milestones to verify the project is on track.

GS-13:
In addition, to qualify for a Clinical Trials Specialist position at the GS-13 level you must demonstrate at least one year of specialized 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: (1) Reviewing progress reports to ensure adherence to budgets; (2) Developing and maintaining standard operating procedures for adverse event data collection; (3) Training clinical research staff on policies and procedures impacting clinical trials; (4) Reviewing protocols to ensure compliance with all organizational policies; and (5) Preparing site visit reports and providing recommendations to senior officials.

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: https://apply.usastaffing.gov/ViewQuestionnaire/12928735

How you will be evaluated

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

You will be evaluated based on how well you meet the qualifications listed in this vacancy announcement. Your qualifications will be evaluated based on your application materials (e.g., resume, supporting documents), your responses on the application questionnaire, and your responses to all assessments required for this position. You will be assessed on the following competencies:

• Attention to Detail
• Customer Service
• Flexibility
• Integrity/Honesty
• Interpersonal Skills
• Reading Comprehension
• Self-Management
• Stress Tolerance
• Teamwork

Overstating your qualifications and/or experience in your application materials or application questionnaire may result in your removal from consideration. Cheating on an assessment may also result in your removal from consideration.

Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.

To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP)and the Interagency Career Transition Assistance Program (ICTAP), you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least 80 points on the assessment(s) and meet all eligibility, physical, medical, suitability, and all other requirements.

The position(s) advertised in this announcement are covered by the agency's Reemployment Priority List (RPL). RPL candidates will be rated, placed into one of the quality categories below, and referred to the hiring office, once veterans' preference is applied.

• Qualified
• Well Qualified
• Best Qualified

Required for All Applicants
RESUME:

Your resume must clearly demonstrate, in two pages or less, how your skills and experiences align with the "Qualifications" section and support your questionnaire responses. While cover letters provided with your application will be shared with hiring officials, they will not be used for initial qualification determinations. We cannot assume required experience based on your work or academic history. If your resume exceeds two pages, only the first two will be reviewed. Use a legible font such as Lato, Calibri, Helvetica, or Arial, with 0.5-inch margins. Suggested formatting: 14-point for titles and 10-point for body text. You may use the USAJOBS Resume Builder or upload your own resume. If uploading, ensure it includes all required information and is organized so we can match the following to each position:

1. Job title
2. Employer name
3. Employment dates (MM/DD/YYYY)
4. Hours worked per week (full-time assumed; part-time prorated)
5. Detailed duties, accomplishments, skills, responsibilities, and supervisory details (if applicable)
6. Series and grade or equivalent (for federal positions)

If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.

Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.

For resume writing guidance, please visit the following resources: NIH Help Applying, USAJOBS Resource Center, and the USAJOBS Resume Guidance.If the position has an education requirement or you are qualifying on the basis of education, you need to list your education history including the type of degree and your major of study.

APPLICATION QUESTIONNAIRE:
You must submit a completed application questionnaire.

ELIGIBILITY DOCUMENTATION:
You must submit the following documentation, if applicable to you AND respond accordingly to the associated question on the online questionnaire. If you do not provide the required information, we will assume you are not eligible or you do not wish to be considered for any preference or eligibility.

• SF-50 - A copy of your most recent competitive career or career conditional SF-50 that shows the effective date of your latest position and the full performance level. You may obtain a copy of your SF-50 from your eOPF.
• Veteran Documentation: (DD-214, VA Disability Letter, etc.). Reference Standard Form 15 (SF-15) for required documentation if you are a 10-point preference eligible. Submission of SF-15 is not required, unless you have derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point preference eligibles, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
• Schedule A (Disability Appointment): Documentation of eligibility for employment under Schedule A can be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead. Please note the Schedule A hiring authority neither guarantees employment, nor gives an individual preference in the hiring process.
• Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP)for more information and required documentation.

Do not submit documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official(s).

Next steps