Manager - Research Regulatory - FT - Days - Office of Human Research
Memorial Healthcare System

Job Info

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Location:
Hollywood, Florida

At Memorial, we are dedicated to improving the health, well-being and, most of all, quality of life for the people entrusted to our care. An unwavering commitment to our service vision is what makes the difference. It is the foundation of The Memorial Experience.

Summary:

Reporting to the Director of Clinical Research, the Clinical Research Regulatory Manager supports and oversees regulatory affairs operations. The primary responsibility will be to manage the overall regulatory process and identify issues, and to independently determine whether the components of the research studies are in compliance with federal, state and local regulations, MHS policies, IRB requirements, and accreditation standards.

Responsibilities:

Audit operations and data submission, including clinical and laboratory procedures, to ensure compliance with applicable regulations. Draft reports for senior management and external regulatory bodies as appropriate.Enhance research portfolio through communications with sponsors and academic partners and coordinate site visits.Provide direction to a team of regulatory coordinators that submit industry and national sponsored trials to IRB and safety committees for approval according to established policies and guidance.Hire, orient, train, and conduct performance reviews for staff handling research and regulatory administration activities associated with the conducting of clinical trials. Review the work of research staff when necessary to identify regulatory and compliance issues and provide advice or training.Monitor Institutional Review Board submissions, IND/IDE and respond to requests and questions. Support internal stakeholders with regulatory/compliance examination requests and drafting responses to regulatory findings.Coordinate new protocol submissions, renewals, and revisions to Local and Central Institutional Review Board for multiple studies.

Competencies:

ACCOUNTABILITY, ACCURACY, CUSTOMER SERVICE, DEVELOPS RELATIONSHIPS, EFFECTIVE COMMUNICATION, PROJECT MANAGEMENT, RESEARCH - BUDGETING, RESPONDING TO CHANGE, STANDARDS OF BEHAVIOR

Education and Certification Requirements:

Bachelors (Required)

Additional Job Information:

Complexity of Work: This role requires critical thinking skills, effective communication, decisive judgment, and the ability to build and foster positive relationships. The incumbent must be able to lead others and take appropriate action when required. Required Work Experience: Five (5) years of related clinical research regulatory experience required. Other Information: Previous managerial experience preferred.Additional Education Info: Foreign Medical Degree or 10 years of related research experience in lieu of Bachelors degree is acceptable.

Working Conditions and Physical Requirements:

• Bending and Stooping = 0%
• Climbing = 0%
• Keyboard Entry = 80%
• Kneeling = 0%
• Lifting/Carrying Patients 35 Pounds or Greater = 0%
• Lifting or Carrying 0 - 25 lbs Non-Patient = 80%
• Lifting or Carrying 2501 lbs - 75 lbs Non-Patient = 0%
• Lifting or Carrying > 75 lbs Non-Patient = 0%
• Pushing or Pulling 0 - 25 lbs Non-Patient = 80%
• Pushing or Pulling 26 - 75 lbs Non-Patient = 0%
• Pushing or Pulling > 75 lbs Non-Patient = 0%
• Reaching = 0%
• Repetitive Movement Foot/Leg = 0%
• Repetitive Movement Hand/Arm = 80%
• Running = 0%
• Sitting = 80%
• Squatting = 0%
• Standing = 80%
• Walking = 80%
• Audible Speech = 80%
• Hearing Acuity = 80%
• Smelling Acuity = 0%
• Taste Discrimination = 0%
• Depth Perception = 80%
• Distinguish Color = 80%
• Seeing - Far = 80%
• Seeing - Near = 80%
• Bio hazardous Waste = 0%
• Biological Hazards - Respiratory = 0%
• Biological Hazards - Skin or Ingestion = 0%
• Blood and/or Bodily Fluids = 0%
• Communicable Diseases and/or Pathogens = 0%
• Asbestos = 0%
• Cytotoxic Chemicals = 0%
• Dust = 0%
• Gas/Vapors/Fumes = 0%
• Hazardous Chemicals = 0%
• Hazardous Medication = 0%
• Latex = 0%
• Computer Monitor = 80%
• Domestic Animals = 0%
• Extreme Heat/Cold = 0%
• Fire Risk = 0%
• Hazardous Noise = 0%
• Heating Devices = 0%
• Hypoxia = 0%
• Laser/High Intensity Lights = 0%
• Magnetic Fields = 0%
• Moving Mechanical Parts = 0%
• Needles/Sharp Objects = 0%
• Potential Electric Shock = 0%
• Potential for Physical Assault = 0%
• Radiation = 0%
• Sudden Decompression During Flights = 0%
• Unprotected Heights = 0%
• Wet or Slippery Surfaces = 0%

Shift:

Primarily for office workers - not eligible for shift differential

Disclaimer: This job description is not intended, nor should it be construed to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with the job. It is intended to indicate the general nature and level of work performed by employees within this classification.

Wages shown on independent job boards reflect market averages, not specific to any employer. We encourage candidates to talk to their Memorial Healthcare System recruiter to discuss actual pay rates, during the hiring process.

Memorial Healthcare System is proud to be an equal opportunity employer committed to workplace diversity.

Memorial Healthcare System recruits, hires and promotes qualified candidates for employment opportunities without regard to race, color, age, religion, gender, gender identity or expression, sexual orientation, national origin, veteran status, disability, genetic information, or any factor prohibited by law.

We are proud to offer Veteran's Preference to former military, reservists and military spouses (including widows and widowers). You must indicate your status on your application to take advantage of this program.

Employment is subject to post offer, pre-placement assessment, including drug testing.

If you need reasonable accommodation during the application process, please call 954-276-8340 (M-F, 8am-5pm) or email TalentAcquisitionCenter@mhs.net

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