Oncology Regulatory Research Coordinator II - FT - Days - MCI Clinical Research

Summary

Candidates with Oncology Regulatory clinical research experience highly preferred. Coordinates and assists with the implementation of multiple clinical research studies. Processes and ships research specimens per protocol guidelines. Responsible for completing, organizing, and submitting Institutional Review Board (IRB) for phase 1 - 4 trials required by the sponsor. Conducts initiation, monitoring and close out visits with the sponsor. Collaborates to ensure the compliance with local, state and federal regulations and standards. Assists with responding to and preparing for audits and participates in audits. Manages the handling of adverse events, compliance and other participant-related issues. Handles resolution of data queries with sponsor. Responsible for training and educating staff. Coordinates the preparation and delivery of departmental communications, presentations and marketing/educational materials.

Responsibilities

• Candidates with Oncology Regulatory clinical research experience highly preferred.
• Captures and documents study progress and results.
• Coordinates and assists with the implementation of multiple clinical research studies.
• Processes and ships research specimens per protocol guidelines.
• Completes, organizes, and submits Institutional Review Board (IRB) for phase 1 - 4 trials required by the sponsor.
• Conducts initiation, monitoring and close out visits with the sponsor.
• Collaborates to ensure the compliance with local, state and federal regulations and standards.
• Assists with responding to and preparing for audits and participates in audits.
• Manages the handling of adverse events, compliance and other participant-related issues.
• Handles resolution of data queries with sponsor.
• Responsible for training and educating staff.
• Captures and documents study progress and results.
• Coordinates the preparation and delivery of departmental communications, presentations and marketing/educational materials.

Requirements

• Two (2) years of clinical research experience required.
• High School Diploma or Equivalent.

Qualifications

• High School Diploma or Equivalent (Required).

Skills

• ACCOUNTABILITY
• ACCURACY
• Clinical Research - Regulatory Compliance
• CUSTOMER SERVICE
• DEVELOPS RELATIONSHIPS
• EFFECTIVE COMMUNICATION
• RESEARCH - REPORTING
• RESPONDING TO CHANGE
• STANDARDS OF BEHAVIOR

Benefits

N/A

Pay

N/A

Schedule

N/A

Additional Job Information

Complexity of Work: Requires critical thinking skills, effective communication skills, decisive judgment and the ability to work with minimal supervision. Demonstrates ability to work effectively as a team member. Ability to multi-task.

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 = 60% Walking = 60% 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 = 40% Communicable Diseases and/or Pathogens = 0% Asbestos = 0% Cytotoxic Chemicals = 0% Dust = 0% Gas/Vapors/Fumes = 0% Hazardous Chemicals = 0% Hazardous Medication = 0% Latex = 40% 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 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