Do you have experience in providing high-level quality assurance and control for clinical research? The National Institute of Mental Health (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. The incumbent in this position is viewed as an expert resource by the mental health research community.

Duties

Development and implementation of guidelines and standards for the conduct of clinical trials in order to ensure data quality and compliance with regulatory requirements for clinical research. Ensures that NIMH-sponsored clinical trials are conducted according to the highest standards by providing expert and regulatory knowledge. Provides expert leadership through ongoing interactions with staff, principal investigators, and study staff. The incumbent reviews and evaluates clinical protocols, consent documents, and study forms, to ensure all NIMH and GCP requirements are met. Maintains expert knowledge of current issues in clinical trials through attendance at scientific meetings and educational seminars.

Requirements

• 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 (please submit a copy of your transcripts when applying)
• 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.

Qualifications

To qualify for a Clinical Trials Program Coordinator at the GS 0601-13 level 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 you must: Demonstrate in your resume at least one (1) year of qualifying 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: managing quality assurance and control for clinical research programs; following guidelines and standards for the conduct of clinical trials; monitoring clinical research projects and documentation; reviewing clinical protocols, consent documents, and study forms; and coordinating clinical trials with other scientists, staff, and organizations. 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12014661

Education

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.

Contacts

• Address National Institutes of Health 6701 Rockledge Dr Bethesda, MD 20892 US
• Name: Donna Baker
• Phone: 301-594-2283
• Email: [email protected]