Research Compliance and Education Specialist - FT - Days - Office of Human Research

Posted:
7/8/2024, 3:47:08 AM

Location(s):
Florida, United States

Experience Level(s):
Junior ⋅ Mid Level

Field(s):
Legal & Compliance

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:

Essential: * Bachelors

Education equivalent experience: Essential: * in science, healthcare or RN degree or background as a medical professional.er information

Required Work Experience: Three (3) years of experience as a monitor, research specialist/study coordinator, or a regulatory coordinator. Prior Oncology and/or hematology experience preferred, including experience in research auditing, monitoring or quality assurance/quality control.
Certified as CHRC, ACRP or SOCRA certification preferred.-Working with the Monitoring & Compliance Officer, will develop and implement a program of continuous Quality Assurance (QA) and Quality Improvement (QI) to ensure research compliance with federal, state, and local regulations and institutional policies to promote quality, ethical and compliant research within the institution. Conducts research education for new research employees including OHR, Pharmacists, Physicians, Nurses and Residents.

Responsibilities:

Participate in and assist with the preparation and training of investigators, residents, fellows, new research staff and pharmacist educational programs.

Review Eligibility criteria for the Medical Research team when manager is not available, and/or for registry studies.

Performs source data verification of all clinical trial related documentation (e.g. investigator qualifications, staff training, Electronic Medical Record and research source documentation, etc.), issuing queries as needed, to ensure proper adherence to SOPs and applicable regulatory requirements.

Review 100% of all newly completed ICFs for completeness and accuracy.

Completes monitoring reports and communicates monitoring results to OHR department leadership and research team, including Principal Investigators Manages post-monitoring activities and follow-up on any necessary corrective and preventive actions; escalates unacceptable findings to OHR leadership, as appropriate.

Independently schedule, coordinate and conduct protocol/project specific for cause audits related to allegations of research non-compliance, high risk, high enrollment or randomly selected investigator protocols, including providing monitoring for investigator initiated trials and preparation for external audits.

Assist Research Specialists with the filing of Protocol Deviations and Serious Adverse Event reporting.

Competencies:

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

Education and Certification Requirements:

Bachelors (Required)Driver's License Num (DRIVER LIC) - Department of Motor Vehicles

Additional Job Information:

Complexity of Work: Ability to problem solve and multi-task, excellent computer skills and proficiency of the English language. Requires critical thinking skills, effective communication skills, decisive judgment and the ability to work with minimal supervision. Demonstrated ability to work effectively as a team member. Proficient in Windows, MS Word, Excel. Driving to our different hospitals to conduct on site audits/monitoring. Required Work Experience: Three (3) years of experience as a monitor, research specialist/study coordinator, or a regulatory coordinator. Prior Oncology and/or hematology experience preferred, including experience in research auditing, monitoring or quality assurance/quality control. Other Information: Certified as CHRC, ACRP or SOCRA certification preferred.Additional Education Info: in science, healthcare or RN degree or background as a medical professional.

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 = 0%
  •  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 = 0%
  •  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 [email protected]