What are the responsibilities and job description for the Oncology Regulatory Research Coordinator II - FT - Days - MCI Clinical Research position at Memorial Healthcare System?
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
Coordinates and assists with the implementation of multiple clinical research studies.
Responsibilities
Candidates with Oncology Regulatory clinical research experience highly preferred.
Assists in training/mentoring of CRC I and other team members as requiredProcesses 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.
Competencies
ACCOUNTABILITY, ACCURACY, CLINICAL RESEARCH - REGULATORY COMPLIANCE, CUSTOMER SERVICE, DEVELOPS RELATIONSHIPS, EFFECTIVE COMMUNICATION, RESEARCH - REPORTING, RESPONDING TO CHANGE, STANDARDS OF BEHAVIOR
Education And Certification Requirements
High School Diploma or Equivalent (Required)
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. Required Work Experience: Two (2) years of clinical research experience required.
Working Conditions And Physical Requirements
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
Summary
Coordinates and assists with the implementation of multiple clinical research studies.
Responsibilities
Candidates with Oncology Regulatory clinical research experience highly preferred.
Assists in training/mentoring of CRC I and other team members as requiredProcesses 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.
Competencies
ACCOUNTABILITY, ACCURACY, CLINICAL RESEARCH - REGULATORY COMPLIANCE, CUSTOMER SERVICE, DEVELOPS RELATIONSHIPS, EFFECTIVE COMMUNICATION, RESEARCH - REPORTING, RESPONDING TO CHANGE, STANDARDS OF BEHAVIOR
Education And Certification Requirements
High School Diploma or Equivalent (Required)
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. Required Work Experience: Two (2) years of clinical research experience required.
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%
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