- 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
- 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.
- 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.
-
Regulatory Compliance Specialist
2 weeks ago
U-Haul International, Inc Phoenix, United StatesLocation:2721 N Central Ave, Phoenix, Arizona 85036 United States of America. Primary Function: Under the direction of the Director of Compliance, research and analyze legal and regulatory issues in order to provide executive summary and recommendati Compliance Specialist, Regula ...
-
Clinical Research Regulatory Specialist
3 weeks ago
Arizona Cardiovascular Research Center Phoenix, United StatesCompany Description · Arizona Cardiovascular Research Center is the largest arrhythmia and heart failure clinical trial center in the Southwest. Our trials cover a broad range of topics related to cardiac electrophysiology and interventional cardiology. · Role Description · This ...
-
Regulatory Compliance Specialist
1 week ago
U-Haul Phoenix, United StatesLocation: · 2721 N Central Ave, Phoenix, Arizona 85036 United States of America · Are you ready to bring your low-key, kick-ass skills to the world of regulatory compliance? Do you thrive on diving into legal and regulatory issues and making sense of complex information? If so, ...
-
Regulatory Specialist
2 weeks ago
WIVERSE Phoenix, United StatesAre there any approved expenses for this position (Cell Phone, Mileage, Internet)? Cell phone and internet · Role · Maintain Regulatory compliance for area Client Sites with regards to governmental and Crown Castle policy. Provide guidance and training to stakeholders regarding r ...
-
Regulatory Affairs Senior Specialist
1 week ago
Cambridge Investment Research (USA) Phoenix, United StatesOverview: · Cambridge is looking for someone with critical thinking skills and an interest in research and collaboration with others to join our Legal and Risk department as a full time Regulatory Affairs Senior Specialist working from our Phoenix, Arizona office. This position ...
-
Clinical Research Regulatory Specialist
1 week ago
DocTrials Phoenix, United States**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 o ...
-
Sr. Regulatory Affairs Specialist
2 weeks ago
MILLENNIUMSOFT Tempe, United StatesPosition: Sr. Regulatory Affairs Specialist · Location: Tempe, AZ · Duration: 12+ Months Contract · Total Hours/week: 40.00 · 1st Shift · Client: Medical Device Company · Job Category: Regulatory Affairs / Compliance · Employment Type: Contract on W2 (Need US Citizens Or G ...
-
Regulatory Compliance Specialist
2 weeks ago
WIVERSE Chandler, United States12-month contract / May extend or convert / Eligible for medical/dental/vision benefits after 90 days · Maintain Regulatory compliance for area Sites with regards to governmental and policy. Provide guidance and training to stakeholders regarding regulatory compliance as needed. ...
-
Auto Claims Specialist
1 week ago
CHUBB Phoenix, United States Regular - Full timeThe Auto Claims Specialist is responsible for handling and managing complex coverage, liability investigations, and settlement negotiations for 1st and 3rd party auto claims. They will analyze first reports, contact insured/claimants promptly, and evaluate contract language to id ...
-
Onboarding Specialist
2 days ago
VeeAR Projects Inc. Phoenix, United StatesPosition: Onboarding Specialist · Location: Phoenix, AZ & Salt Lake, UT (Hybrid) · Duration: 12+ months (Possible Extension) · Primary Responsibilities: · The CAS Global Client On-Boarding team is looking for a team member to support an assigned portfolio of prospects, assist wi ...
-
Financial Dispute Specialist
4 days ago
24 Seven Talent Phoenix, United StatesOur financial client in Phoenix, AZ is looking for a Financial Dispute Specialist for this 5 days/week onsite opportunity. This is a 3 month contract with potential to extend. If the contract extends beyond 3 months, you'd be eligible for benefits and more. · Ideal Candidate: 2-4 ...
-
Environmental Specialist
4 days ago
Trinity Consultants Engineering & EHS Workforce Solutions Arizona, United StatesResponsibilities: · Develop and implement various environmental plans and response protocols. · Keep up to date with federal, state, and local environmental regulations by attending periodic training courses. · Participate as requested in environmental compliance and various othe ...
-
QA Document Control Specialist
4 days ago
Unical Aviation Inc. Phoenix, United StatesPosition Summary: · The Document Control Specialist is responsible for managing the creation, revision, distribution, retrieval, and archiving of documents within an organization to ensure accuracy, quality, and compliance with regulatory standards. Overall, document control spec ...
-
Environment, Health and Safety Manager
3 weeks ago
Net2Source Inc. Phoenix, United StatesNet2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting companies across the USA and we are hiring " Visitor Relations Specialist " for one of our clients. We offer ...
-
Brokerage Account Specialist
1 week ago
Experis Phoenix, United StatesBrokerage Account Specialist - MUST HAVE Current Series 7 License · Are you a customer service champion with a passion for helping people? · Do you have a strong understanding of financial markets and regulatory requirements? · If so, we want to hear from you OUR CLIENT is seekin ...
-
Laboratory Supervisor
1 week ago
Phoenix Children's Phoenix, United States Full timePosition Summary This position works collaboratively with section director, manager, and leadership team to provide technical supervision for assigned staff to ensure high quality daily technical operations. Achieve and comply with established operating budget, quality control, ...
-
Banking Specialist
2 days ago
Motion Recruitment Phoenix, United StatesTitle: Onboarding Specialist · Type: 12 Month Contract, Potential to Extend · Location: Hybrid; Onsite 2 Times Per Month in Either Phoenix, AZ or Salt Lake City, UT · Benefits: Medical, Dental, 401K, Life Insurance · Our client, an innovative bank, is seeking a talented Onboardin ...
-
Senior Client Care Specialist
2 weeks ago
Western Alliance Bank Phoenix, United States Full timeJob Title: · Senior Client Care Specialist Location: · CityScape What you'll do: · As a Client Care Specialist you will focus on displaying a high level of client service, and providing a professional, prompt, and accurate banking experience and exemplify the department's "s ...
-
Contract Specialist
4 weeks ago
Insight Global Phoenix, United StatesA large Financial Services company is looking for a Contract Specialist to join their team The role is responsible for building and maintaining stakeholder relationships with the business in US Market. The Contracts Manager will be required to negotiate legal contracts and commer ...
-
Global Financial Crimes Investigator
1 week ago
Bank of America Phoenix, United States Full timeDescription · : · This job is responsible for performing end-to-end investigations or investigations support functions of external financial crimes activities across one or more lines of business. Key responsibilities include conducting routine to complex investigations, includi ...
Clinical Research Regulatory Specialist - Phoenix, United States - DocTrials
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Regulatory and Quality Assurance SpecialistTL;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
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.