Job description

The Gateway Institute for Brain Research is a scientific research organization dedicated to furthering the understanding of Parkinson’s Disease and like neurodegenerative disorders. Gateway is actively seeking a Quality Assurance Specialist to assist with Gateway’s regulatory efforts FDA regulatory compliance for current and upcoming clinical trials. This is an exciting opportunity for a motivated, experienced, clinical research compliance professional to join a diverse team at a research institute utilizing in vivo , in vitro , in silico , and clinical research for the development of new treatments for neurodegenerative disorders.

This position is based at the Gateway Institute for Research office in the Center for

Collaborative Research on the Nova Southeastern University campus in Davie, Fl and

comprises a combination of remote and on-site work.

RESPONSIBILITIES:

The incumbent’s chief responsibility will be to ensure compliance with applicable state

and federal law/regulations - International Council for Harmonisation Guidance, Food

Drug and Cosmetic Act, applicable portions of the Code of Federal Regulations, etc. -

through the creation and implementation of internal policies and procedures and the

audit of Gateway’s various departments. The Quality Assurance Specialist works closely

with the Clinical Trials Manager, Director of Quality Assurance, Director of Information

Systems, and General Counsel to accomplish tasks.

Duties include:

● Develop, update, and maintain standard operating procedures (SOPs) related to

Gateway’s clinical and pre-clinical research operations.

● Establish and maintain compliance with current Good Manufacturing Procedures (cGMP) and

regulatory guidelines.

● Identify key risk indicators and develop quality management processes, risk

assessments, and risk mitigation strategies.

● Work with cross functional teams to ensure appropriate delegation of tasks and

completion of risk mitigation strategies.

● Assist with the validation, implementation, and maintenance of electronic systems (i.e.

electronic Trial Master File, Electronic Data Capture).

● Train applicable staff on SOPs and monitor compliance.

● Provide periodic reports to department leaders and escalate issues as necessary,

follow up with preventative and corrective action plans when needed.

● Perform monitoring and auditing activities for sponsor and clinical site operations.

● Provide compliance training to new staff members and perform periodic continuing

education training for all applicable staff.

● Perform vendor validation and audits of contract research organizations , other

third-party vendors, and electronic systems.

● Work with research and clinical operations to review Investigational New Drug

submission documents, including initial submissions and various amendments.

● Other duties as assigned.

REQUIREMENTS :

● Bachelor’s degree required

● Sponsor-level FDA compliance experience required

● Strong understanding of the regulatory framework, and associated FDA and ICH

Guidance, applicable to the creation, development, and approval of drugs and biologics,

including those regulations applicable to preclinical and clinical trials.

● Must be a self-starter and have a strong ability to work independently

● CCRP, CCRC, ASQ or monitoring/auditing certification highly preferred

● At least 6 years of experience in clinical research in an FDA-regulated environment.

At least 4 years in a compliance role.

● Experience with electronic systems (eTMF, eISF, etc.) a plus

● Some travel may be required

Job Type: Full-time

Salary: $60,000.00 - $75,000.00 per year

Benefits:

● 401(k)

● 401(k) matching

● Dental insurance

● Flexible schedule

● Health insurance

● Life insurance

● Paid time off

● Vision insurance

Schedule:

● Monday to Friday

Supplemental pay types:

● Bonus pay

Ability to commute/relocate:

● Davie, FL 33314: Reliably commute or planning to relocate before starting work

(Required)

Experience:

● clinical research in an FDA-regulated environment: 6 years (Required)

Shift availability:

● Day Shift (Required)

Work Location: Hybrid remote in Davie, FL 33314

Job Type: Full-time

Pay: $60,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 6 years

Schedule:

• Monday to Friday

Work setting:

• Hybrid remote

Ability to commute/relocate:

• Davie, FL 33314: Reliably commute or planning to relocate before starting work (Required)

Experience:

• clinical research in an FDA-regulated environment: 6 years (Required)
• compliance role: 4 years (Required)

Shift availability:

• Day Shift (Required)

Willingness to travel:

• 25% (Preferred)

Work Location: Hybrid remote in Davie, FL 33314

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