Regulatory and Quality Assurance Specialist

TL;DR

As a Regulatory and Quality Assurance 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.