2 Supervisory Regulatory and Clinical Operations Specialist Jobs in Frederick, MD
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Supervisory Regulatory and Clinical Operations Specialist
$91k-112k (estimate)
Full Time
1 Week Ago
USAJOBS is Hiring a Supervisory Regulatory and Clinical Operations Specialist Near Frederick, MD
Duties
In addition, in order to qualify for a Supervisory Regulatory and Clinical Operations Specialist, GS-0601-15, you must have at least one year of qualifying specialized experience equivalent to at least the GS-14 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: providing leadership, oversight, and guidance on regulatory requirements for clinical trials for Investigational New Drug and Investigational Device Exemption applications; providing expertise and guidance on regulations, policies, and procedures governing clinical trials operations and regulatory applications; overseeing the preparation of reports on clinical trials operations and regulatory issues; overseeing and providing guidance on the development of clinical trial protocols; and providing supervision and direction to other staff.
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: https://apply.usastaffing.gov/ViewQuestionnaire/12426864
EducationThis 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
- Managing all Sponsor clinical operations obligations as listed in ICH GCP E6 section 5.
- Managing all Sponsor activities for sites assessment, initiation, activation and close out.
- Developing SOPs and processes in support of those actives.
- Serve a supervisor for the clinical operation team and serve as the COR or COR representative for OSRO support contract.
- Providing expert guidance to investigators, team members, and pharmaceutical partners, on clinical operations to support clinical trials in new and commercial drugs and devices used in the treatment of cancer.
- Providing expert guidance to investigators, team members, and pharmaceutical partners to ensure IND/IDE study protocols, reports, and documentation conform to applicable guidelines and regulations. The candidate must remain current on trends and patterns in the health sciences/allied science and medical research fields and regulations governing IND/IDEs.
- Reviews, adverse drug reaction reports to determine the implications for current and planned research, and initiates necessary actions, including modification of specific protocol and overall drug development plans.
- Provides leadership and direction for the following functions of the OSRO: Protocol Development and Review; Development, Support, and Oversight of Clinical Trial Procedures; Training and Quality Assurance Functions; and Liaison, Coordination, and Advisory Functions.
- 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 transcript(s).
- A one-year supervisory trial/probationary period may be required upon selection/placement.
In addition, in order to qualify for a Supervisory Regulatory and Clinical Operations Specialist, GS-0601-15, you must have at least one year of qualifying specialized experience equivalent to at least the GS-14 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: providing leadership, oversight, and guidance on regulatory requirements for clinical trials for Investigational New Drug and Investigational Device Exemption applications; providing expertise and guidance on regulations, policies, and procedures governing clinical trials operations and regulatory applications; overseeing the preparation of reports on clinical trials operations and regulatory issues; overseeing and providing guidance on the development of clinical trial protocols; and providing supervision and direction to other staff.
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: https://apply.usastaffing.gov/ViewQuestionnaire/12426864
EducationThis 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.
- If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. This information is required annually. For information, visit the NIH Ethics website: https://ethics.od.nih.gov/topics/fd.html .
- A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
- A one-year probationary period may be required upon selection/placement.
- PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration
- We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions.
- 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.
Job Summary
JOB TYPE
Full Time
SALARY
$91k-112k (estimate)
POST DATE
06/20/2024
EXPIRATION DATE
07/14/2024
WEBSITE
usajobs.gov
HEADQUARTERS
Washington, TX
SIZE
50 - 100
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