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Covenant Metabolic Specialists · 2 days ago

Regulatory Specialist

Tampa, FL

Full-time

Onsite

Entry, Mid Level

2+ years exp

Covenant Metabolic Specialists (CMS) is a leading medical practice dedicated to the clinical management and education of metabolic diseases. They are seeking a dynamic Regulatory Specialist to provide regulatory leadership across all clinical trials and ensure compliance with applicable regulations and guidelines.

EducationHospitalMedical

Responsibilities

Lead regulatory activities for all clinical trials, ensuring compliance with applicable regulations and guidelines

Direct and oversee short-term and long-term planning of regulatory submission initiatives

Develop and implement strategies for the earliest possible approval of regulatory submission and ensure all regulatory documents/logs are up to date

Complete Study-related IRB submissions, in a timely manner

Collaborate with internal teams, including Compliance, Site Leadership, and Study Start-Up to ensure timely and high-quality submissions

Serve as a regulatory resource for internal stakeholders, providing guidance on best practices and submission expectations

Manage regulatory elements and provide guidance to team

Plan, schedule and direct activities for study sponsor or monitors visits

Monitor regulatory requirements and industry trends to ensure ongoing compliance and proactive planning

Assist with outside agencies as needed to resolve key regulatory issues

Must attend meetings and share regulatory updates. Communicate changes and updates to staff and management, in a timely manner

Participate in audits and be audit ready at all times

Retrieve and distribute IRB approved documents, informed consents, and study-related documents in a timely manner

Coordinate and prepare document packages for regulatory submissions ensuring compliance

Assist with preparing outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to team

Educate Investigators, Coordinators, and other staff re: IRB and Regulatory standards and responsibilities

Create and maintain well organized, complete eRegulatory files

Ensure Delegation Logs are up to date at all times

Ensure staff is current on all general regulatory trainings

Other duties may be assigned

Qualification

Regulatory submissionsIRB requirementsClinical research experienceMicrosoft Office SuiteEffective communicationCross-functional collaborationOrganizational skillsProblem solving

Required

Bachelor's degree in life science, or related field required; equivalent education and relevant experience may be accepted

Requires 2-4 years of clinical research experience, primarily in developing and submitting successful regulatory submissions

Strong knowledge of IRB requirements and Federal and State regulations as they relate to research

Ability to manage multiple priorities and deadlines in a fast-paced environment

Effective communication and cross-functional collaboration skills

Ability to work independently with minimal supervision

Demonstrated excellent written, oral, communication, presentation, planning and interpersonal skills for effective collaboration with cross-functional teams and regulatory agencies

Excellent organizational skills with a strong attention to detail

Critical thinker and problem solver

Professional, friendly, outgoing personality; maintain a positive attitude under pressure

Proficiency in Microsoft Office Suite

A high level of self-motivation and energy with an optimistic, 'can do' attitude