Regulatory Maintenance Specialist

Adams Clinical, Inc.; New York (NY); Vor Ort; USD 45.000 - 75.000; Vollzeit

Benefits dieser Stelle

401(k) matching

Employee assistance program

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Parental leave

Zusammenfassung

The Regulatory Maintenance Specialist at Adams Clinical, Inc., Bronx site, ensures ongoing study compliance and inspection readiness from activation through closeout. You’ll manage IRB approvals, staff credentialing, and sponsor/CRA action items, working with site operations to safeguard data quality and participant safety.

Collaborating with a cross-site regulatory team, you’ll leverage CRIO eReg and Form FDA 1572 updates, while maintaining audit readiness and timely documentation across the

Qualifikationen

• Bachelor's degree in life sciences, clinical research, or a related field.
• 1-2 years of clinical trial experience; regulatory experience preferred.
• Working knowledge of GCP and IRB processes; familiarity with FDA regulations and 21 CFR Part 11 preferred.
• Experience with eReg or eSource systems preferred (CRIO a plus).
• Strong written and verbal communication skills with PIs, sponsors, CROs, and site teams.

Aufgaben

• Distribute IRB approvals, amendments, and ICF updates, and verify that site staff are informed before study activities proceed.
• Submit continuing reviews, protocol deviations, and other required reports to the IRB within established timelines.
• Maintain version control so only current, approved ICFs and study documents are in use.
• Complete regulatory onboarding for new staff, including Form FDA 1572 updates, training logs, and delegation of authority log entries.
• Track licenses, certifications, and training expirations, and prompt renewals before they lapse.
• Maintain regulatory binders and study files in CRIO eReg in a state of continuous audit readiness.
• Resolve sponsor and CRA action items from monitoring visits, and respond to document requests, within established timelines.
• Submit IRB termination reports, end staff delegation, and complete closeout documentation.
• Coordinate records retention and archiving.
• Partner with the central start-up team for a smooth handoff at study activation.
• Participate in twice-weekly check-ins and monthly regulatory team meetings to share updates and best practices.

Kenntnisse

Regulatory maintenance

IRB processes

GCP familiarity

FDA regulations

eReg/eSource systems

Staff credentialing

Audit readiness

Documentation management

Communication with PIs/sponsors

Ausbildung

Bachelor's degree in life sciences

Tools

CRIO eReg

Jobbeschreibung

Join Us in Shaping the Future of Clinical Research

Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromising data quality, safety, and diverse enrollment to advance healthcare. Our vision is to set the gold standard for clinical trial excellence. We believe our people makethedifference. Guided by our core values— Scientific Rigor, Operational Excellence, Commitment to Sponsors and Participants, and Authentic Collaboration—we create an environment where meaningful work drives meaningful change.

At Adams Clinical,you’llfind:

• A culture of respect, transparency, and continuous improvement
• Opportunities for professional growth and learning
• A team dedicated to improving lives through innovation and integrity

Ifyou’repassionate about making an impactinclinical research and want to be part of a collaborative, mission-driven organization,we’dlove to have you on our team.

Job Role

The Regulatory Maintenance Specialist serves as the regulatory owner for the Bronx site, ensuring that every active study remains compliant and inspection ready from activation through closeout. This role combines hands on regulatory expertise with operational discipline, meticulous attention to detail, and close partnership with site operations to protect data quality and participant safety.

The Regulatory Maintenance Specialist is responsible for managing IRB approvals and amendments, maintaining staff credentialing and delegation, resolving sponsor and CRA action items, and sustaining continuous audit readiness. Reporting to the Central Regulatory Maintenance Manager, this position partners with site staff, PIs, sponsors, and CRAs, and collaborates with regulatory colleagues across our six-site network. Supported by twice weekly team check ins, monthly regulatory meetings, and centralized study start up support, the role is measured against specific goals tied to performance bonuses. This is an onsite position with potential for a couple of work from home days.

Key Responsibilities:

IRB & Study Document Management

• Distribute IRB approvals, amendments, and ICF updates, and verify that site staff are informed before study activities proceed.
• Submit continuing reviews, protocol deviations, and other required reports to the IRB within established timelines.
• Maintain version control so only current, approved ICFs and study documents are in use.

Staff Credentialing & Delegation

• Complete regulatory onboarding for new staff, including Form FDA 1572 updates, training logs, financial disclosure forms, and delegation of authority log entries.
• Track licenses, certifications, and training expirations, and prompt renewals before they lapse.

Audit Readiness & Sponsor Support

• Maintain regulatory binders and study files in CRIO eReg in a state of continuous audit readiness.
• Resolve sponsor and CRA action items from monitoring visits, and respond to document requests, within established timelines.

Study Closeout

• Submit IRB termination reports, end staff delegation, and complete closeout documentation.
• Coordinate records retention and archiving.
• Partner with the central start-up team for a smooth handoff at study activation.
• Participate in twice-weekly check-ins and monthly regulatory team meetings to share updates and best practices.

Job Requirements:

• Bachelor's degree in life sciences, clinical research, or a related field.
• 1-2 years of clinical trial experience; regulatory experience preferred.
• Working knowledge of GCP and IRB processes; familiarity with FDA regulations and 21 CFR Part 11 preferred.
• Experience with eReg or eSource systems preferred (CRIO a plus).
• Strong written and verbal communication skills with PIs, sponsors, CROs, and site teams.
• Collaborative and respectful, with a kind, patient approach to working with site staff and colleagues, including under tight deadlines.
• Results-driven, taking ownership, following through, and adapting as priorities shift.
• Detail-oriented and thorough, catching discrepancies such as outdated ICF versions and confirming documents are filed and communicated to the right people.

Pay:

$60-75k salary, commensurate with experience

• 401(k) matching
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave

Adams Clinical is committed to being an equal opportunity and affirmative action employer. We focus on hiring and nurturing top talent. All employment decisions, including recruitment, hiring, promotion, compensation, transfer, training, discipline, and termination, are made based on the candidate’s or employee’s qualifications relevant to the position. These decisions are made without regard to age, sex, sexual orientation, gender identity or expression, genetic information, race, color, creed, religion, ethnicity, national origin, citizenship, disability, marital status, military status, pregnancy, or any other legally protected status.

In compliance with federal law, all individuals hired must, as a condition of employment, provide documentation verifying their identity and authorization to work in the United States and complete Form I-9 within the requiredtime frame. Adams Clinicalparticipatesin E-Verify to confirm employment eligibility.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Adams Clinical's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.