Nurse (Research Specialist)

Summary

The ideal candidate will have experience in adult and / or pediatric clinical research studies as a Research Nurse Specialist who is highly skilled in implementing clinical research protocols, recruiting patient volunteers to participate in clinical trials, coordinating multiple studies, collecting and analyzing research data, FDA communications, interpreting IND regulations, and assisting in the publication of clinical trial results.

Duties

As a Nurse (Research Specialist) your duties will include but, are not limited to the following :

• Developing, implementing, and assesing process improvement strategies for compliance with applicable regulations and SOPs.
• Collaborating with the principal investigator to finalize, ensure implementation, assess efficacy, and revise corrective and preventive action plans.
• Assuring compliance of clinical trial objectives and endpoints.
• Supporting the informed consent process by continually providing patient / family counseling related to clinical trials and to the clinical trials process.
• Identifying trends, facilitators, and barriers in recruitment and retention.
• Interviewing and evaluating all patients being screened for entry into clinical trials.

If you are selected at the GS-12 level, you will essentially perform the same duties at the full performance level described above, however, duties will be less complex, and will be performed under closer supervision, with more detailed guidance.

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.
• Licensure Requirement : Professional Nursing License required.
• This position is designated as an "non-emergency / teleworker" position. See definition of this designation in the Additional Information Section of this announcement.
• 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).
• At the supervisor's discretion, this position may offer work schedule flexibilities : telework and alternative work schedules.
• If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
• The work requires some physical exertion such as long periods of standing, or recurring and considerable crouching, bending, standing, stooping, stretching, or walking.
• The work involves regular and reoccurring exposure to moderate risks, discomforts, and unpleasantness such as infectious diseases, harmful chemicals and / or biological hazards.

Protective clothing and equipment are necessary.

Qualifications

BASIC EDUCATION REQUIREMENT :

Completion of a Graduate or higher level degree, bachelor's degree, associate degree, or diploma from an accredited professional nursing educational program is required.

This education must have been accredited by the Commission on Collegiate Nursing Education, Council on Accreditation of Nurse Anesthesia Educational Programs, Accreditation Commission for Midwifery Education, or an accrediting body recognized by the U.

S. Department of Education at the time the degree was obtained.

Completion of a Degree from Foreign Nursing School : Official certification from the Commission on Graduates of Foreign Nursing Schools (external link) is required for individuals who graduated from foreign nursing schools.

LICENSURE REQUIREMENTS :

You must have passed the National Council Licensure Examination for Registered Nurses (NCLEX-RN).

You must possess a current, active, full, and unrestricted license or registration as a professional nurse from a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.

ADDITIONAL QUALIFICATIONS :

To qualify for the GS-12 grade level :

• In addition to the education and license requirement, you must demonstrate in your resume at least one year of qualifying 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 : Interviewing and evaluating new patients and assessing their eligibility for clinical trials;
• assisting in evaluating patient trends and contributing to the design of clinical trials; coordinating and facilitating the collection of research specimens to assure accurate, valid clinical data;
• identifying and communicating the impact of the research process on patient care, then adjust interventions based on findings;

providing counseling to patients and family members on the basis of treatment protocols, clinical trials, or research studies as well as the roles of various team members, protocol specifics and anticipated schedule of events.

To qualify for the GS-13 grade level :

• In addition to meeting the education and licensurerequirements,you must demonstrate in your resume at least one yearqualifying 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 : planning, designing, and developing clinical research protocols;
• interviewing, screening, and recruiting patients for entry onto research studies; generating research questions as a result of new study procedures or interventions;
• directing and performing quality assurance and quality control activities as they relate to study adherence, study monitoring, data collection, data abstraction, and data analysis;
• providing guidance to healthcare professionals in the administration of research programs, including the ethical and legal aspects of nursing care and clinical trials;

and assuring compliance of clinical trials objectives and endpoints while monitoring and evaluating participant responses to treatments and reporting potential adverse events.

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.

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.

The position(s) advertised in this announcement are covered by a direct hire authority. Traditional rating and ranking of applicants, including category rating, does not apply to this vacancy.

You will be initially evaluated against the basic qualifications only. Qualified applicants will be referred for consideration in accordance with the .

Veterans' Preference does not apply to positions covered by a direct hire authority.

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 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 r. 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 :

• Job title
• Name of employer
• Beginning and ending dates of employment (month / day / year format)
• Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
• Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory / managerial responsibilities and number of staff supervised (if applicable)
• 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 CAREER TRANSITION CLAIMS

Visit our websites to claim selection priority through the Career Transition Assistance Program (CTAP) or the Interagency Career Transition Assistance Program (ICTAP) :

• CTAP :
• ICTAP :

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.

Please do not submit any other supplementary 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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