Protocol Implementation Expert (PIE)

Protocol Implementation Expert (PIE) / Fully Remote / Flexible Hours / $180K - $200K / health, vision, and dental insurance, ancillary health benefits / 401k.

My client is a rapidly growing market leader that seeks a Protocol Implementation Expert to join their dynamic team. My client are a company that is making a difference in improving the human condition by disrupting the conduct of clinical trials through digital innovation and having fun doing it.

This company is raising the bar on what can be achieved in clinical trials training. We are the first company to field interactive, immersive virtual training simulations to eliminate protocol deviations and optimize the quality of clinical trials. Your work here contributes to the cutting edge of medical research - the field that has done the most to improve quality of life. This company is hot, it’s growing fast, and they are taking the market by storm.

Their training modules combine expert video production, animation and 3-D modeling to simulate real world decisions that investigators and site staff must make during the conduct of a clinical trial. By making critical decisions in a consequence-free environment, learners develop competency in the protocol execution without putting real subjects and data at risk. By tracking decision-points through each module, our analytics dashboards provide visibility to the sites and staff who are at risk for deviating from the protocol. This enables sponsors and CROs to remediate skill gaps before they cause real problems in multi-million-dollar clinical trials. Clinical trial content is often dry, and it requires tremendous creativity to envision ways to make it interesting and engaging for our users (physicians/Investigators, study coordinators and other site staff). Their creativity and technology are just two of the reasons why they are winning in the clinical trial space, but it’s the real impact they are making that drives the team and delights their clients!

What is your role on the team?

As our Protocol Implementation Expert, you will:

? Analyze and dissect clinical research protocols for investigational new drugs and devices, to

? Identify operational challenges and hurdles sites will face when implementing the protocol

? Areas of inconsistency or inaccuracy to provide recommendations to make the protocol more clear and understandable

? Engage with Clinical Operations and Medical Monitor / Clinical Science team members on the client site (sponsors/CROs) to evaluate the operational challenges and uncover how they plan to mitigate the challenges

? Use the above information to create:

? Immersive, interactive training modules on relevant topics (e.g., eligibility, IP preparation and administration, subject safety management, etc.)

? Case-study vignettes that will simulate the real-life problems site staff will encounter so that they can practice decision-making and problem solving in our simulation-based training environment

? Decision-support tools to facilitate the implementation of the studies (e.g., job aids, operations manuals)

? Work closely with our Video Producers to:

? Write the script and create the storyboards that will bring the training content to life

? QC the draft videos and content to ensure accuracy

? Work closely with our Simulation Producers to:

? Manage timelines and budget for the creation of the training modules and decision-support tools

? You will also help to develop Principal Investigator simulation-based training modules and competency assessments using the ACRP-PI Competency Framework (built from the Joint Task Force (JTF) Competency Framework

? You will follow similar methodologies and approaches for creating protocol-specific training to help ‘X’ build out our more generic new PI training modules

? This effort may expand to other clinical research roles over time

What will make you successful in this role?

? Ability to untangle complex protocols and associated documents and to identify areas needing clarity

? Strong client-facing abilities (communications, asking the “whys” about how studies were designed) to help operations and clinical science team members get aligned on successful protocol implementation and mitigation strategies

? Desire to work with talented video producers to help visualize complex information into simple and compelling visuals and videos

? Willingness to be flexible and adjust with the ebbs and flows of client deadlines

? Strong interest and willingness to learn about new methods for enhancing learning

? Ability to work with and learn different software systems for content development and supporting module development within our eLearning Platform (including Keynote / PowerPoint, Monday.com project management system, Frame.io and others)

Subject Matter Expertise

? Strong knowledge of clinical research operations and implementing / monitoring clinical trial implementation at investigative sites

? Deep understanding of factors contributing to important protocol deviations and Good Clinical Practice (GCP) compliance issues at sites and how to prevent them

? Practical and applied experiences teaching investigative site personnel GCPs through a variety of teaching modalities

? Good working knowledge of the JTF Competency Framework for Clinical Research Professionals

Other Core Competencies

? Strong interpersonal skills

? Ability to establish credibility and build strong client relationships

? Flexibility to work with changing priorities and processes

? Creative thinking and strong problem solving abilities

Entrepreneurial Spirit

? Desire to work in a scrappy startup environment where you can drive new ventures within the business

? Ability to take initiative and work with limited direction

? Ability to work comfortably in a fast-paced environment

? Strong, effective time management skills

? Energized by the flexibility to perform well when granted the ability to set your own schedule and goals

Required Minimum Qualifications:

? The Protocol Implementation Expert will possess a bachelor’s degree in a healthcare, education or life-sciences related field

? They will have more than 10 years of related or applicable clinical research operations experience working at or with investigative sites such as Clinical Research Coordinator, Site Director, Clinical Research Associate, Clinical Trial Manager or Clinical Research Trainer / Educator

? The ideal candidate will have a passion for operationalizing and optimizing clinical trials and enhancing the competency of clinical research professionals

What’s in it for you?

This company is a fun, creative and rewarding work environment. They take pride in our quirky culture and stand by our core values. Their company is experiencing rapid growth. Their customers are multi-billion-dollar pharmaceutical companies, and they are helping them improve their clinical trial process. They are offering great benefits for salaried positions, including health, vision, and dental insurance, ancillary health benefits, 401k. They also offer flexible hours with remote work. However, this industry is pretty much one strike you’re out. They always hit their clients’ deadlines and sometimes this requires long hours. To compensate, they offer unlimited paid time off and they’ll want you to take it! Your creative mind needs rest and relaxation to work at its best.

My client is an equal opportunity employer and does not discriminate or allow discrimination on the basis of race, color, religion, gender, age, national origin, citizenship, disability, veteran status or any other classification protected by federal, state, or local law. This company promotes affirmative action for minorities, women, disabled persons, and veterans.