Summary

Do you have experience in the management and oversight of ethical, regulatory, and safety aspects of observational studies and clinical trials?

Multiple Clinical Trials Specialist positions are available in the following Divisions in the National Heart, Lung, and Blood Institute:

Duties

As a Clinical Trials Specialist, you will:

• Effectively establish overall priorities for the oversight of clinical trials, monitoring performance and providing guidance.
• Plan, develop, and implement targeted research programs.
• Manage protocol development for clinical studies supported by the Division.
• Ensure protocol compliance with guidelines (e.g., inclusion of women, minorities and children in clinical research; reporting adverse events, etc.).
• Develop protocol budgets as needed.
• Collaborate with the Data Coordinating Center (DCC) to prepare Manuals of Operation and other study documents such as recruitment brochures, website content, etc.
• Review adverse events, adverse events files, and reports and analyses; ensuring timely and accurate evaluation and reporting of adverse events in accordance with NHLBI policy.
• Use clinical judgement, and in consultation with medical officers, assess possible risks for patient safety, evaluate adequacy of safety data collection and management, and recommend and implement remedial action or propose new scientific study.

The incumbent is under closer supervision and receives more detailed instructions at the GS-12 level. As the incumbent progresses, the complexity and pace of the duties increase and the incumbent will work with greater independence. This position has a full performance level of GS-13.

Requirements

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 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

Basic Qualifications

In order to qualify for a Clinical Trials Specialist, GS-0601 position: You must have completed a full 4 year course of study in an accredited college or university leading to 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.

Additional Qualifications

In order to qualify for a Clinical Trials Specialist, GS-0601 position at the GS-12 level, you must have 1 year of specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector performing the following types of tasks: preparing comprehensive reports summarizing the progress on clinical trials; conducting clinical trials and targeted research programs; and assisting with protocol development, implementation, clinical site monitoring, and contributing to the presentations of clinical research.

In order to qualify for a Clinical Trials Specialist, GS-0601 position at the GS-13 level, you must have 1 year of specialized experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector performing the following types of tasks: performing oversight and management pertaining to the regulatory and procedural aspects of clinical research/clinical trials; developing protocol budgets; managing protocol development for clinical studies and monitoring performance; directing the development and maintenance of standard operating procedures for adverse event data collection; and establishing overall priorities for the oversight of clinical trials and performance evaluation.

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.

To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings with the information you provide in your application. 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 assessment questionnaire before you apply:

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. Knowledge of regulations, policies, and procedures relating to the conduct of clinical trials.
• 2. Ability to manage and oversee clinical trial research programs.
• 3. Ability to communicate effectively about clinical trials.
• 4. Ability to apply experimental theories to solving complex health care problems.

If you meet the minimum qualifications for this position, your application and responses to the online questionnaire will be evaluated under Category Rating and selection procedures for placement in one of the following categories:

• Best Qualified - for those who are superior in the evaluation criteria
• Well Qualified - for those who excel in the evaluation criteria
• Qualified - for those who only meet the minimum qualification requirements

The Category Rating Process does not add veterans' preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Applicants determined to be Best Qualified will be referred for further consideration. Preference eligibles in the Best Qualified category are referred before all other applicants.

To be considered well qualified for the purposes of the and the , you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least an 85 on the assessment and meet all eligibility, physical, medical, suitability, and all other requirements.

Required Documents

REQUIRED FOR ALL APPLICANTS
RESUME:
Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.

To ensure all of the essential information is in your resume, we encourage you to use the . If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

1. Job title
2. Name of employer
3. Beginning and ending dates of employment (month/day/year format)
4. Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
5. Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
6. Series and grade or equivalent (if a federal position)

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: , , and the .

ASSESSMENT QUESTIONNAIRE:
You must submit a completed assessment questionnaire.

Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.

REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS
To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.

• (DD-214, VA Disability Letter, etc.): Reference for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming 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 claims, 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 is submitted with your application package.
• Visit our sites on / for more information and required documentation.
• Visit our site on the for more information and required documentation to verify eligibility.
• Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under must submit appropriate documentation to verify eligibility. Documentation must 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 and signed. Veterans' preference takes precedence in these appointments.

The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.

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.

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 or hiring manager.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from .

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

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