Do you have experience in providing high-level quality assurance and control for clinical research? NIMH is looking for a Clinical Trials Program Coordinator who has knowledge of mental health clinical trials research, clinical trial design and methodology, data and safety monitoring, and federal policies and guidance on research with human subjects from NIMH, NIH, and agencies/offices such as FDA and OHRP, so please make sure to highlight and thoroughly describe your experience in your resume.
Summary
Do you have experience in providing high-level quality assurance and control for clinical research? NIMH is looking for a Clinical Trials Program Coordinator who has knowledge of mental health clinical trials research, clinical trial design and methodology, data and safety monitoring, and federal policies and guidance on research with human subjects from NIMH, NIH, and agencies/offices such as FDA and OHRP, so please make sure to highlight and thoroughly describe your experience in your resume.
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.
Duties include but are not limited to the following:
Provide oversight and monitoring of clinical trials, federal regulations including NIH, Office for Human Research Protections (OHRP), Office of Research Integrity (ORI) and Institutional Review Board (IRB) policies and procedures.
Development and implementation of data, safety and monitoring plans and the monitoring and oversight of clinical trials.
Assists with the development and implementation of corrective action plans
Provides strategic guidance and leadership in the development and dissemination of innovative methodologies to improve the efficiency of clinical trials.
Maintains current expert knowledge of clinical trials methodologies, monitoring and oversight procedures, HHS and federal policy and procedures in areas of responsibility through reading of current literature and staying abreast of new policies and regulations related to clinical trials.
Provides ongoing monitoring, review and evaluation of study documents, data, safety and monitoring reports, the preliminary and final audit reports, and any follow up responses.
Conducts monitoring, comprehensive reviews and evaluations of assigned clinical research projects and information found in a wide range of study documents to ensure compliance with all applicable federal regulations, policies, and procedures with regards to the conduct of clinical trials and clinical practice.
Communicates clinical trial findings to senior leadership, proposing corrective actions to resolve problems.
Leads the continual development and refinement of systems used to oversee the management and efficiency of projects, monitor risk and quality assurance of clinical trials and compliance with all applicable Federal regulations, policies and procedures.
Provides expert leadership through ongoing interactions with NIMH staff, principal investigators, and study staff.
Develop and implement well-designed, effective informatics tools and procedures to evaluate clinical trial progress and conducts risk-based evaluations.
Participate in meetings and serves as the NIMH representative and expert in clinical trials management conduct and oversight.
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 the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
Males born after December 31, 1959 must be registered with the Selective Service.
Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
Position requires Education, please submit a copy of your transcripts.
Qualifications
In order to qualify for a Clinical Trials Program Coordinator, GS-601, position, you must:
Have successfully 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).
In addition, in order to qualify for a Clinical Trials Program Coordinator, GS-0601 at the GS-14 level, you must:
Demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-13 level in the Federal service obtained in either the private or public sector, performing the following types of tasks:managing quality assurance and control for clinical research programs; developing and implementing guidelines and standards for the conduct of clinical trials; provide guidance to research staff on regulations, policies, and procedures governing the conduct of clinical trials; monitoring clinical research projects and documentation; reviewing clinical protocols, consent documents, and study forms; developing systems to oversee the management and efficiency of clinical research projects; and coordinating clinical trials with other scientists, staff, and organizations.
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.
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.
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
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.
A one-year probationary period may be required upon selection/placement.
This position is eligible for non-local remote work, a position designation where little to no onsite presence is required (e.g., once or twice annually). You may work anywhere in the U.S., including any of the territories. Worksites outside of the U.S. are prohibited. Your pay is determined by the geographically defined pay locality applicable to your approved worksite (e.g., home residence). Reporting to an NIH location may also be required during the onboarding process. Visit NIH's Remote Work page for more information and requirements.
This position is eligible for local remote work, a position designation where onsite presence is required only on an irregular or infrequent basis, not to exceed two days or 16 hours every two weeks. Your worksite (e.g., home residence) must be within the Washington-Baltimore-Arlington pay locality to be eligible. Visit OPM's page for pay locality definitions. Visit NIH's Remote Work page for more information and requirements.
PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration.
Veterans' Preference applies only to Schedule A (disability appointment) and Veterans Recruitment Appointments (if applicable).
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 Applicant FAQs page for helpful information on the application process.
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.
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 for the conduction of clinical trials.
2. Skill in monitoring clinical research projects.
3. Skill in evaluating clinical research studies for progress, efficiency, and compliance.
4. Ability to collaborate and coordinate work activities with other organizations, officials, and staff.
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 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 by 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 having knowledge of your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin prior to receiving an offer. 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 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.
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 USAJOBS online Resume Builder. 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)
Performance ratings and any monetary or non-monetary awards
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. 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.
ASSESSMENT QUESTIONNAIRE:
You must submit a completed assessment questionnaire.
ELIGIBILITY/PREFERENCE 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 human resources office or, if you are an HHS employee, from your eOPF. If you separated from Federal Government employment, you may obtain a copy of your SF-50 via the Federal Records Center, National Archives and Records Administration.
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 and signed. Please note the Schedule A hiring authority neither guarantees employment, nor gives an individual preference in the hiring process.
Documentation to support any other noncompetitive or OPM interchange agreement eligibility. Reference the Eligibility section of the questionnaire for required documents and information.
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:
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.
To apply for this position, please read and follow all instructions in this announcement, complete the online application, and submit the documentation specified in the "Required Documents" section. Your complete application package must be submitted by 11:59 PM Eastern Time (ET) on 04/21/2023 to receive consideration.
To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the "Required Documents" section for any additional forms and/or supplemental materials required.
Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package.
Complete the assessment questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/11833453
Verify all required documentation is included in your application package, review your responses to the assessment questionnaire for accuracy, and then submit your application.
In addition to the required documents, we encourage you to submit a cover letter, copy of your transcripts, and any applicable certifications or licenses. Even though this information is not required at the time of application, we may request this information later.
We cannot assume responsibility or grant extensions for personal issues (e.g., troubles navigating the application process, loss of internet, not understanding a question) when applying to our announcements. For technical difficulties, contact HR Systems Support between 8:00 AM and 4:30 PM ET Monday through Friday at hrss@nih.gov.
If you need any other accommodation or assistance with applying, please contact Donna Baker at gaetanorellandm@mail.nih.gov. Requests for reasonable accommodations must be made before the announcement closing date.
National Institutes of Health
6701 Rockledge Dr
Bethesda, MD 20892
US
Next steps
HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.
Once you submit your application package, you will receive an acknowledgement email. You will be notified of the status of your applications via email. In addition, you can track the progress of your application package through your USAJOBS account.
At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
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 USAJOBS online Resume Builder. 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)
Performance ratings and any monetary or non-monetary awards
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. 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.
ASSESSMENT QUESTIONNAIRE:
You must submit a completed assessment questionnaire.
ELIGIBILITY/PREFERENCE 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 human resources office or, if you are an HHS employee, from your eOPF. If you separated from Federal Government employment, you may obtain a copy of your SF-50 via the Federal Records Center, National Archives and Records Administration.
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 and signed. Please note the Schedule A hiring authority neither guarantees employment, nor gives an individual preference in the hiring process.
Documentation to support any other noncompetitive or OPM interchange agreement eligibility. Reference the Eligibility section of the questionnaire for required documents and information.
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:
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.
To apply for this position, please read and follow all instructions in this announcement, complete the online application, and submit the documentation specified in the "Required Documents" section. Your complete application package must be submitted by 11:59 PM Eastern Time (ET) on 04/21/2023 to receive consideration.
To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the "Required Documents" section for any additional forms and/or supplemental materials required.
Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package.
Complete the assessment questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/11833453
Verify all required documentation is included in your application package, review your responses to the assessment questionnaire for accuracy, and then submit your application.
In addition to the required documents, we encourage you to submit a cover letter, copy of your transcripts, and any applicable certifications or licenses. Even though this information is not required at the time of application, we may request this information later.
We cannot assume responsibility or grant extensions for personal issues (e.g., troubles navigating the application process, loss of internet, not understanding a question) when applying to our announcements. For technical difficulties, contact HR Systems Support between 8:00 AM and 4:30 PM ET Monday through Friday at hrss@nih.gov.
If you need any other accommodation or assistance with applying, please contact Donna Baker at gaetanorellandm@mail.nih.gov. Requests for reasonable accommodations must be made before the announcement closing date.
National Institutes of Health
6701 Rockledge Dr
Bethesda, MD 20892
US
Next steps
HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.
Once you submit your application package, you will receive an acknowledgement email. You will be notified of the status of your applications via email. In addition, you can track the progress of your application package through your USAJOBS account.
At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
