Bilingual Clinical Research Coordinator

DocTrials, LLC; Phoenix, Northern (AZ, KY); Hybrid; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health insurance

Dental & vision

Paid time off

Bonus structure

Retirement plan

Flexible schedule

Company adventures

Job summary

DocTrials, LLC in the Phoenix area (Northwest Valley & Phoenix locations) is seeking a Clinical Research Coordinator to manage patient visits and lead interventional protocols across 5+ offices. You will ensure FDA/ICH-GCP compliance and oversee enrollment with strong organizational skills.

You must have at least 1 year of clinical research experience, be fluent in English and Spanish, and hold a Bachelor's degree. Local travel is required at times.

Qualifications

• Minimum 1 year clinical research experience.
• Bachelor's degree required.
• Fluency in English and Spanish.
• Ability to coordinate across multiple sites.
• Familiarity with FDA regulations and ICH-GCP.

Responsibilities

• Coordinate patient visits and independently conduct complex interventional/therapeutic protocols in compliance with FDA regulations and ICH-GCP.
• Lead patient acquisition to meet enrollment goals across Phoenix offices.
• Develop and maintain relationships with Sponsor, CRO, and physician specialists.
• Identify, document, and report adverse events and protocol deviations; liaise with labs as needed.
• Maintain drug records, dispensing history, and patient education; monitor adherence to study rules.
• Obtain training and credentials for tasks defined by study protocols; perform study source checks.
• Read and relay study information using a project management platform, Basecamp; update documents accordingly.
• Collect patient vitals, draw labs, and process shipments as required.

Skills

Attention to detail

Multitasking

Project management

Communication

Bilingual English/Spanish

Time management

Patient care

Education

Bachelor's degree

Tools

Basecamp

Job description

TL;DR

Northwest Valley & Phoenix Locations

As 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 challenge, you pull from your experience, grab your tools, and execute a plan. You consider yourself a rule follower, but able to pivot if the situation calls for it. When given an assignment, you are the project manager, set your own deadlines, AND crush them. Patient care and excellent bedside manner is a top priority for you. Your hobbies include reading, checking things off your to-do list, and creative projects. You’re not afraid to think outside the box or work outside of your comfort zone. As a Clinical Research Coordinator, you see yourself further developing your skills to grow your career in a patient-facing setting because you care about the community in which you serve. You have a minimum of 1 year previous clinical research experience. Fluency in English and Spanish required. Bachelor's degree required.

What you will own & improve

• Coordinate patient visits. You will be responsible for independently conducting complex interventional & therapeutic protocols in compliance with FDA regulations and ICH-GCP guidelines. You may coordinate at each of our 5+ offices we work in throughout the Phoenix valley.
• Patient acquisition. You will be responsible for meeting enrollment goals for studies in which you are assigned as lead by means of chart review, lunch-and-learns, and other community outreach activities.
• Cultivate positive relationships. Develop and maintain strong connections with all of our customers (Sponsor/CRO & Physician Specialists).
• Adhere to strict safety parameters. You will be responsible for identifying, documenting, and reporting adverse events, protocol deviations, and other unanticipated problems. Duties may include liaising with laboratories regarding findings. All the while consulting with the Principal Investigator and patient in order to assess patient eligibility into the trial and throughout their participation.
• Drug records and dispensing. You are responsible for maintaining detailed records regarding drug receipt, dispensing, and maintenance. This includes patient education and monitoring adherence to study rules
• Assessments and exams. You are responsible for obtaining training, certification, and maintaining credentials to perform various tasks as defined by study protocols.
• Process important study information. You will be responsible for reading and internalizing incoming information from study bulletins, newsletters, and memos. This information may require you to update documents and relay this information to the team by utilizing a project management platform, Basecamp.
• Vitals, phlebotomy and laboratory. You will be responsible for collecting patient vitals, drawing labs, as well as processing and shipping samples.

What you already know

• You have a minimum of 1 year clinical research experience, so you already know the basics. For example, you can rattle off these acronyms in your sleep: EDC, GCP, ICF, SIV/IMV/COV, AE/SAE, and DOA.
• You have experience reviewing patient charts in order to assess eligibility for enrolling trials. You’re not afraid to pick up the phone to screen a patient for a new study and by the time you’re done the two of you are BEST buds.
• How to effectively manage your time when there is a lot on your plate. You’ve got tried and true techniques to keep you on tasks, meeting your own deadlines, and setting yourself up for success.
• Previous experience in or passion for ophthalmology is a major plus!

What you will learn

• As the project manager of the studies you are assigned as lead, you will learn to execute timely study start-up, develop source documents, and manage monitoring visits.
• You will learn how to perform quality assurance checks and audit patient source and regulatory files.
• Regulatory tasks such as file maintenance, start-up document execution and collection, and IRB reporting guidelines.

About the Team

This role reports to our Director of Clinical Research.

Local travel is required

Benefits at DocTrials

• Competitive salary
• Health insurance
• Dental & vision
• Paid time off
• Bonus structure
• 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.