Clinical Research Regulatory Specialist

4 weeks ago

Phoenix, United States DocTrials Full time
Job DescriptionJob DescriptionSalary:

Regulatory and Quality Assurance Specialist

 

TL;DR

As a Clinical Research Regulatory Specialist, you love to-do lists, organization, and are a master of administrative tasks. You have pronounced attention to detail and are obsessed with learning. As a lifelong seeker of knowledge you read everything Dotting all your i's and crossing all your t's is a top priority for you. You are a superstar at Word, Excel and organization of electronic documents and files. When faced with a challenge, you grab your resources, open your manuals, and search until the answer can be found You are an eager self-starter who wants to develop a strong foundation to grow in clinical research regulatory and administrative duties. You may or may not have some previous clinical research experience. Bachelor's degree required.


What you will own & improve

  • Monitoring visit prep: preparation ownership and training of staff on monitoring visit prep to-dos. Schedule times to meet with the lead coordinator to complete tasks. Personally complete tasks and follow-up with staff until completion.
  • Study Meetings: You attend and run them all PSV, SIV, IMV, COV. Provide training and give tours of source and regulatory to monitors.
  • Credentialing: Maintain CVs for all physicians, staff, and study staff members; update appropriately. Track GCP training expirations and issue reminders for completion; file certificates.
  • Regulatory compliance: conducts Trial Master File maintenance, IRB reporting, submissions, approval processing, and more. Complete internal processes for protocol amendment and ICF amendments.
  • Study Start-Up: Assist with execution of initial regulatory packets. Ensures the study hits the ground running when green light is received.
  • Site organization and upkeep: Manage study supplies, inventory, prepping, and ordering. Document and destroy expired supplies on a regular basis.
  • Study CTMS maintenance: You will become a CTMS super user completing tasks within Clinical Trial Management Software (CTMS), eSource, eDocs and more. 
  • Process important study information: Relay information from study bulletins, newsletters, and memos to the team by utilizing a project management platform, Basecamp.
  • Internal Monitoring: Conduct thorough quality assurance checks of source and regulatory. Support in the conduct of mock inspections of trials across all sites. 
  • SOP Review: Review SOPs on a regular basis to ensure adherence. Escalate proposed changes to management.
  • Sponsor/CRO Monitor Relations: Develop business relationships with on-site Sponsor/CRO staff. Assist with scheduling and preparing for pre-study visits.
  • Study Close-Out:  Manage the QA and archiving process and organization across all sites. 
  • Reporting - Run and analyze weekly reports 
    • IMV prep outstanding for following week
    • EDC entered (QC)
    • Temperatures being logged and in range
    • Source complete & uploads complete


What you already know

  • Regulatory basics like how to properly add staff to studies, execute an initial regulatory packet, and prepare for monitoring visits. 
  • Quality assurance fundamentals like how to perform an internal check of source prior to monitor review. 
  • General knowledge of ICH-GCP guidelines. 
  • How to stay organized and manage a large variety of tasks and timelines.
  • You know your way around a computer, printer, scanner.  You consider yourself tech savvy and pick up on new platforms quickly.
  • Possess strong written, verbal and interpersonal skills.


What you will learn

  • You will establish a strong foundation of skills to grow as a Regulatory and Quality Assurance Manager who oversees trials across multiple sites in compliance with FDA regulations and ICH-GCP guidelines.
  • How to perform specific start-up and regulatory functions 
  • How to cultivate a positive working relationship with all of our customers (Sponsor/CRO & Physician Specialists). Further business development by participating in study acquisition activities, identifying study leads, and following up until selection.
  • How to grow a Regulatory and Quality Assurance department packed with internal monitoring processes, inspection team, and regulatory compliance committee. 


About the Team

This role reports to the Regulatory & Quality Assurance Manager or Director of Clinical Operations.

Local travel is required.


Benefits at DocTrials

Competitive salary

Health insurance

Dental & vision

Paid time off

Bonus structure

Cell phone stipend

Mileage reimbursement

Retirement plan

Flexible schedule

Company adventures


Values at DocTrials

Align Your Daily Priorities

Roll Out the Red Carpet

Be obsessed about learning

Show Up Ready

What Can We Do?

Don’t Panic

Don’t Work in a Bubble

Recognize the Gray

Have a positive purpose


About Us

DocTrials' culture is guided by our values and behavior. Our success depends on how much we care for each other, our customers, and our community.

 

DocTrials is an alliance of physician sites specializing in the conduct of clinical studies within their private practices. Sites in the alliance work under DocTrials' core standard operating procedures and quality control measures that provide a methodology ensuring the highest quality control and best practice utilization across sites. This provides assurance and confidence to sponsors that they will achieve quality data in the most efficient and timely manner. DocTrials was founded with the primary goal of connecting patients and physicians with clinical trials across the US; aiding in the process to discover new therapies, bring hope, and find new treatment for disease.

  • Clinical Research Regulatory Specialist

    1 month ago

    Phoenix, United States DocTrials Full time

    **Regulatory and Quality Assurance Specialist** **TL;DR** As a Clinical Research Regulatory Specialist, you love to-do lists, organization, and are a master of administrative tasks. You have pronounced attention to detail and are obsessed with learning. As a lifelong seeker of knowledge you read everything! Dotting all your i's and crossing all your t's is...

  • Clinical Research Regulatory Specialist

    1 month ago

    Phoenix, United States DocTrials Full time

    Job DescriptionJob DescriptionSalary: Regulatory and Quality Assurance Specialist TL;DRAs a Clinical Research Regulatory Specialist, you love to-do lists, organization, and are a master of administrative tasks. You have pronounced attention to detail and are obsessed with learning. As a lifelong seeker of knowledge you read everything! Dotting all your...

  • Unblinded Clinical Research Coordinator I

    5 days ago

    Phoenix, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionUnblinded Clinical Research Coordinator IDM Clinical Research is looking to hire an Unblinded Clinical Research Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials.Duties & Responsibilities:Compound and dispense prescribed IP.    ...

  • Clinical Research Coordinator

    2 days ago

    Phoenix, United States Center for Orthopedic and Research Excel Full time

    Job DescriptionJob DescriptionMORE Foundation is a non-profit dedicated to Keeping Life in Motion through innovative research, community education and charitable assistance programs. The Foundation conducts both laboratory based and clinical research in collaboration with physician groups and leading healthcare organizations such as The CORE Institute and...

  • Research Coordinator

    1 month ago

    Phoenix, United States IRONWOOD PHYSICIANS,P.C. Full time

    Job DescriptionJob DescriptionIronwood Cancer & Research Centers has beautiful state-of-the-art integrated Cancer and Women's Centers, with locations strategically located throughout the Valley. Each one provides a superior cancer care environment with a full spectrum of cancer related services for patients. Our multi-disciplinary team approach includes...

  • Nutrition Clinical Research Coordinator

    1 month ago

    Phoenix, United States Arizona Veterans Research and Education Foundation Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experience and qualifications; range $30.00 to $32.00 per hourPosition Title: Nutrition Clinical Research Coordinator (CRC)Location: Arizona Veterans Research and Education Foundation is based on the Phoenix VA Medical Center Campus in Phoenix, Arizona. We are near the light rail.Schedule: Part-Time...

  • Clinical Research Coordinator

    10 hours ago

    Phoenix, United States Phoenix Children's Hospital Full time

    Position Details Department: RSRCH-GRNT | BMT Research Studies Category: Research Location: Phoenix Employee Type: Regular Posting #: 826997 Posted On: 3/28/2024 Position Summary This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the...

  • Clinical Research Quality Control Specialist

    6 days ago

    Phoenix, United States Kelly Science, Engineering, Technology & Telecom Full time

    Clinical Product Quality SpecialistKelly Science and Clinical is hiring for a temp-to-perm need for one of our clients who is a leading player in the clinical research field, dedicated to advancing medical science and improving patient outcomes. Their Clinical Department is at the forefront of cutting-edge research. This role will play a pivotal role in...

  • Clinical Research Nurse

    1 month ago

    Phoenix, United States Phoenix Children's Hospital Full time

    **Position Duties**: - Provides nursing care to research study patients, including: - Performs and/or schedules medical tests within the scope of nursing licensure including, but not limited to, laboratory tests, vital sign readings, imaging studies, cardiac and/or pulmonary function tests, and psychological evaluations. - Administers study medications and...

  • Clinical Research Coordinator

    4 weeks ago

    Phoenix, United States American Vision Partners Full time

    Company Intro: At American Vision Partners (AVP), we partner with the most respected ophthalmology practices in the country and integrate best-in-class management systems, operational infrastructure, and advanced technology to provide the highest quality patient care possible. Our practices include Barnet Dulaney Perkins Eye Center, Southwestern Eye Center,...

  • Clinical Research Coordinator

    1 month ago

    Phoenix, United States DocTrials Full time

    Job DescriptionJob DescriptionSalary: TL;DRAs a Clinical Research Coordinator, you have mastered the art of multitasking, prioritizing, and efficiency. Your acute attention to detail has all your peers asking you to proofread their work (which you love doing!). You thoroughly enjoy dissecting and internalizing large amounts of information. When faced with a...

  • Sub-Investigator (Nurse Practitioner)

    2 days ago

    Phoenix, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionSub-Investigator (Nurse Practitioner)  The Sub-Investigator is accountable and responsible for ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of subject generated data and directing the conduct of research according to federal and state regulations and...

  • Lab Technician

    1 month ago

    Phoenix, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionLab TechnicianThe Lab Technician will be responsible for assisting the clinical research staff in conducting clinical research trials.Duties & Responsibilities:Prepares, processes, and ships laboratory samples to outside laboratories following IATA regulations.Conducts venipuncture and phlebotomy on study subjects.Provides...

  • Clinical Research Assistant

    4 weeks ago

    Phoenix, United States DocTrials Full time

    Job DescriptionJob DescriptionSalary: TL;DRAs a Clinical Research Assistant, you love to-do lists, organization, and are a master of administrative tasks. You have pronounced attention to detail and are obsessed with learning. As a lifelong seeker of knowledge you read everything! Patient care and excellent bedside manner is a top priority for you. When...

  • Clinical Research Coordinator

    1 week ago

    Phoenix, United States Medasource Full time

    Opening: Clinical Research CoordinatorStart Date: 5/20Contract: 6-month contract to hireLocation: Onsite (Phoenix AZ).Hard Requirements:Investigator Initiated Trial experienceBeing able to interpret protocol and ensure that it is done correctly.3-5 years of experience minimum with clinical trials.Responsibilities:Coordinates and schedules subject study...

  • Clinical Research Coordinator

    2 weeks ago

    Phoenix, United States Medasource Full time

    Opening: Clinical Research CoordinatorStart Date: 5/20Contract: 6-month contract to hireLocation: Onsite (Phoenix AZ).Hard Requirements:Investigator Initiated Trial experienceBeing able to interpret protocol and ensure that it is done correctly.3-5 years of experience minimum with clinical trials.Responsibilities:Coordinates and schedules subject study...

  • Clinical Research Coordinator

    3 days ago

    Phoenix, United States Medasource Full time

    Clinical Research CoordinatorStart Date: ASAP, flexibleContract: 6 month contract to full-time hireLocation: Onsite (Phoenix AZ).Interview Process: 2 roundsHard Requirements:Investigator Initiated Trial experienceBeing able to interpret protocol and ensure that it is done correctly.3-5 years experience minimum with clinical...

  • Clinical Research Coordinator

    2 days ago

    Phoenix, United States Medasource Full time

    Clinical Research CoordinatorStart Date: ASAP, flexibleContract: 6 month contract to full-time hireLocation: Onsite (Phoenix AZ).Interview Process: 2 roundsHard Requirements:Investigator Initiated Trial experienceBeing able to interpret protocol and ensure that it is done correctly.3-5 years experience minimum with clinical...

  • Clinical Research Coordinator

    5 days ago

    Phoenix, United States Medasource Full time

    Opening: Clinical Research CoordinatorStart Date: 5/20Contract: 6-month contract to hireLocation: Onsite (Phoenix AZ).Hard Requirements:Investigator Initiated Trial experienceBeing able to interpret protocol and ensure that it is done correctly.3-5 years of experience minimum with clinical trials.Responsibilities:Coordinates and schedules subject study...

  • Clinical Research Charge Nurse 224058

    2 days ago

    Phoenix, United States Medix™ Full time

    The Unit Nurse Manager is responsible for the management of the clinical research observation unit, consistent with company policies, principles, strategies, and objectives.ResponsibilitiesServe as supervisor and mentor to all direct reports as detailed by the organizational chart.Complete patient care requirements by scheduling and assigning nursing and...