CLINICAL QUALITY SPECIALIST

Gateway Institute for Brain Research is an international cutting-edge research center dedicated to improving the quality of life for those diagnosed with Parkinson’s Disease, and other neurological conditions, through a combination of in-house research, private sponsorship, and inter-institutional collaboration to expedite the development of novel treatments and foster scientific understanding of Parkinson’s Disease.

Gateway is actively seeking a Clinical Quality Specialist to assist with Gateway’s regulatory efforts and 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 Brain 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 Clinical Quality Specialist works closely with the Clinical Project Manager, Director of Quality Management, 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 research operations.

● Establish and maintain compliance with current Good Clinical Practice (cGCP) and regulatory guidelines.

● Identify key risk indicators and develop quality management processes, risk assessments, gap analysis 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).

● Assist in training of 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 qualification 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

● Strong Sponsor-level FDA/ICH compliance experience required

● Strong understanding of the regulatory framework, associated FDA, and ICH Guidance, applicable to the creation, development, as well as, approval of drugs and biologics. This includes 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

The ideal candidate will have:

• Experience as Clinical Monitor (CRA) and documented evidence of a clinical research educational training program.
• Experience working for a Sponsor organization

Job Type: Full-time

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

Benefits:

● 401(k) with matching contributions

● Health insurance

●Dental insurance

● Vision insurance

● Life insurance

● Paid time off

Supplemental pay types:

● Bonus pay

Ability to commute/relocate:

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

Work Location: Hybrid remote in Davie, FL 33314

Schedule:

● Monday to Friday, Day Shift (Required)

Willingness to travel:

• Up to 25%

Job Type: Full-time

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

Schedule:

• Monday to Friday

Work setting:

• Hybrid work

Education:

• Bachelor's (Required)

Experience:

• Clinical Research: 6 years (Required)

Ability to Commute:

• Davie, FL 33314 (Required)

Ability to Relocate:

• Davie, FL 33314: Relocate before starting work (Required)

Work Location: Hybrid remote in Davie, FL 33314