Matrix Medical Network

Regulatory Coordinator - DCT (Remote Opportunity)

Posted Date 6 days ago(11/24/2021 1:17 PM)
Job ID
2021-16960
# of Openings
1
Category
Biopharmaceutical
Type
Full Time Regular

Overview

 

 

MatrixClinicalTrials_Vertical

 

Regulatory Coordinator, DCT   - Remote Opportunity 

 

 

 

 Matrix Clinical Trials provides rapid and scalable decentralized trial solutions to reach broad and diverse trial participant populations and improve the patient experience. Matrix adheres to the highest standards in quality, compliance, and data collection to accelerate trial completion timelines and support trial partners.

 

To learn more about Matrix Medical Network Clinical Trials please visit:  https://matrixmedicalnetwork.com/clinical-trials/

 

 

What we offer:

    • A chance to work with great people on exciting projects
    • Make a difference by taking the time doing the work that saves lives that have positive and direct impact on the wellbeing of others
    • The opportunity to work with a progressive company, who wants to make a difference
    • Opportunities to travel
    • Matrix Medical Network is proud to be a Diversity, Equity and Inclusion Employer

 

 

 

Responsibilities

 

About the Position:

 

     Type: Full Time Regular

     Compensation: Base + year's of experience 

Location: Primary location is 9201 E. Mountain View, Road, Scottsdale, AZ 85258. Position is remote. 

Hours: Days, some evening, possible occasional weekend hours  

Benefits Offered to include: Medical, Dental, Vision, 401K with company matching, paid time off, paid holidays and eligible for tuition discount to name a few. 

 

 

This position coordinates and facilitates regulatory affairs within Matrix Clinical Trials, in the areas of regulatory, education, training and compliance, including the use of Good Clinical Practice principles with understanding and application of Food and Drug Administration regulations and International Conference on Harminosation-Good Clinical Practice (ICH-GCP) guidelines. Responsible for regulatory implementation and maintenance of study protocols through the lifecycle of the study. Studies are dependent upon the Matrix CT research portfolio, so knowledge of clinical research trials regulations i.e., OHRP, FDA, ICH-GCP is essential.

 

 

Responsibilities: 

 

  • Prepares and submits documents related to the protection of human subjects to the relevant institutional Review Board (IRB) Matrix CT internal review groups and any associated regulatory agencies including but not limited to, new study applications, study amendments, annual reports, IND Safety Reports, informed consent forms and other required regulatory documents.
  • Assists Director & Associate Director of Quality, Regulatory, Education and Compliance with initiating, following-up, negotiating, and resolving issues regarding current and future submissions; participates in direct discussions with the appropriate regulatory agencies and other parties; assists with meeting human subject protection standards in research. As necessary, participates in creation of supporting documents for research involving human subjects.
  • Assists in developing departmental operating procedures
  • Be knowledgeable of local, state and federal regulations that apply to human subject’s research, FDA, ICH-GCP regulations, sponsor guidelines and all Standard Operating Procedures (SOP).
  • Interacts with third-party auditors or inspectors as directed for regulatory compliance and responds to regulatory queries.
  • Execute and maintain a system for maintenance of all regulatory documents, including study-specific regulatory binders. Execute and maintain online database for tracking all study documents.
  • Review sponsor guidelines for each study to ensure compliance with SOPs, suggesting modifications as necessary for compatibility.
  • Performs other duties as assigned, including strategic assignments from the Director & Associate Director of Quality, Regulatory, Education and Compliance.
  • Other duties as assigned.

Qualifications

Must Haves: 

 

  • Bachelor's Degree or 4 years work-related experience Required
  • 2 years experience in clinical research, including data coordination, document and regulatory management, regulatory compliance, and quality assurance required; including previous submissions to an IRB.
  • Strong interpersonal skills, including ability to gain the cooperation of others
  • Able to work effectively with internal and external customers, peers and subordinates
  • Able to read, analyze and interpret information from professional journals, sponsor materials or governmental regulations
  • Experience working and communicating effectively with multiple levels of management and work groups
  • Excellent verbal, written communication and presentation skills and advanced skills in Microsoft Word, Excel, Outlook, REDCap and PowerPoint software packages.
  • Familiarity with assessing regulatory compliance of clinical documentation, investigational sites and vendors

Supervisory responsibilities: None

Travel: Travel may be required for this position. 

 

Our Culture: 

 

  • We have a clear vision of where we are going, and we are guided by core values that embody our organization and our culture.
  • We emphasizes innovation and growth, and you will be given the opportunities and tools to develop personally and professionally.
  • We encourage and celebrate collaboration.
  • We have a deep commitment to positively impact the communities in which we work and to make a difference in the lives of who we serve.
  • As a clinical organization, we support vaccinations because we care about the health and safety of our colleagues and those we serve. Moreover, our clients are increasingly expecting us to be vaccinated due to the vulnerability of those we serve.  As such, Matrix Medical Network requires that all team members are fully vaccinated against Influenza and COVID-19, unless they are eligible for a specific exemption.

 

Matrix Medical Network is an Equal Employment Opportunity Employer. It is the policy of Matrix to provide equal employment opportunities without regard to race, color, religion, sex, gender identity or expression, pregnancy, age, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. It is also the policy of Matrix that qualified individuals with disabilities receive equal opportunity in regard to job application procedures, hiring, and all aspects of the employment process. Matrix is committed to the full inclusion of all qualified individuals. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of Matrix to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship.  If reasonable accommodation is needed to participate in the job application or interview process, pre-employment testing, to otherwise participate in the selection process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact MatrixHR@matrixhealth.net.

 

 

 

Matrix Medical Network is proud to be an Equal Opportunity Employer. Scottsdale, AZ 85258, Remote, Primary Location: Scottsdale, AZ 85258.  Job: DCT Regulatory Coordinator, remote,  Regular Shift. Full Job Level: Day Job,  Travel, Monday, Friday. Job, work at home opportunity, DCT Regulatory Coordinator, clinical trials, DCT, ACRP, CRC, clinical trials research, CRO, Remote Opportunity, Regular, Job Type, Standard, Travel, Pay, hours.    

 

 

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