There is an incredible opportunity for innovation in the drug development process. We are reimagining what’s possible to build a more efficient and sustainable model.Christian Antoni, MD, PhD Chief Global Development Officer
Sr. Clinical Research Associate
EQRx believes responsibility can be revolutionary. Want to make a difference while advancing your career? Come join a team that is working towards our bold mission of developing innovative medicines at radically low prices to help people get the medicines they need.
What You’ll Do
The Sr. Clinical Research Associate will establish and maintain effective project/clinical site communications, create and maintain relevant project documents and ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines, and project plans with project-specific information. You will participate in the clinical investigator recruitment process. This person will perform clinical site evaluation visits of potential investigators and evaluate the capability of the site to successfully manage and conduct clinical studies. You will perform study initiation activities, review protocols with site personnel, manage regulatory issues, maintain study procedures, and provide training on completion of the electronic case report forms; monitor activities and provide study close-out activities. You will train site staff on the electronic data capture system and verify the site computer system. You will assist in resolving any issues to ensure compliance with site file audits and assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. You will perform validation of source documentation and prepare monitoring reports and letters per the timelines. You will document accountability, stability, and storage conditions of clinical trial materials. This role will review the quality and integrity of the clinical data through (1) in house review of electronic case report form data and (2) on-site source verification and perform serious adverse event review and reconciliation. You will serve as primary contact for the site and perform study close-out visits for the study per specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock, and resolution of outstanding action items. You will monitor patient data, site data centrally using appropriate technology for single or multiple studies to ensure high data quality, and patient safety.
You will monitor risk reports and data trending related to quality, safety, efficacy (effectiveness), site performances, budget, etc., generated by analytical and visualization or risk management tools. This person will facilitate early identification of risk/issue(s) occurring during study conduct and be responsible for identification of risk alerts, timely escalation of risk/issue(s) to relevant stakeholders (e.g. study manager), and track risk/issue(s) until resolution. You will keep track of site performance and act as a single point of contact for relevant stake-holders (study managers, safety/medical monitors, data managers, etc.) for allocated risk-based, centralized monitoring studies and ensure timely communication, coordination with these stakeholders. This person will support optimization of source data verification and reduce on-site monitoring visits and be responsible for documentation of centralized monitoring activities e.g. risk/issue(s) findings, escalation, tracking and resolution, etc., during study conduct, etc.
The Impact You Will Have
- This is not your standard Clinical Research position. We are doing things differently here than how it is normally done, and this role is no exception. This position is highly visible and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.
- You have a Bachelor’s degree or registered nurse in a related field or an equivalent combination of education, training, and experience (5+ years).
- You have knowledge of Good Clinical Practice and International Council for Harmonisation Guidelines and other applicable regulatory requirements.
- You have strong knowledge of electronic systems e.g. electronic case report form, electronic Trial File Master, and Clinical Trial Management System.
- You can form strong functional relationships.
- You have experience in risk-based and central monitoring.
- You have experience with policy, guidance, and procedure development and maintenance.
- You have global experience and have driven new system adoption.
- You demonstrate the ability to analyze existing processes and implement effective changes as needed.
- You have Oncology and immuno-inflammatory experience.
- You can coordinate the ongoing evaluation of products technologies, services, and processes.
- You can identify opportunities to reduce costs and improve timelines.
- You are constantly reviewing publications and information sources to keep updated on current regulations, practices, procedures, and proposals.
- You monitor industry best practices, changes in global regulations and guidelines, and recommend changes and upgrades to existing policies, standard operating procedures and systems.
- You have a working knowledge of good clinical practice and International Council for Harmonisation guidelines and in-depth knowledge of clinical research processes, regulation, and methodology.
- You can participate and work effectively on multiple cross-functional teams.
- You play well in the sandbox. You understand relationships are key and have strong interpersonal skills.
- You are a leader. Teams love working with you and you are someone who takes pride in mentoring and supporting the careers of others.
- You can thrive in a smaller company environment and love the pace of a true startup
- You’re a team player who is willing to roll-up your sleeves and get the job done.
Are you bold enough?
Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let’s work together to change the world and bring affordable medicines to all patients.
We aren’t about a bunch of empty slogans on a wall or words on a coffee cup – you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities.
Are you ready to fight for enduring patient access?
- Problem Solving
It’s (mutually) beneficial.
You’re curious about what sets us apart from the rest. What do you get from working at EQRx?
So, let’s start big—working at EQRx means having the opportunity to change the world.
By joining a team that’s remaking medicine development from start to finish, you’re going to enjoy the daily rush of throwing caution to the wind and doing things differently by:
- Working with the smartest game-changers in the industry
- Cutting down the red tape of “the way things are done”
- Seeing and feeling the daily impact of your work
- Growing as a professional and a person
- Committing to neverending social responsibility
And, yes—we also have a killer list of things that’ll help you shine as part of the team.
But to us, these are just table stakes.
- 100% Medical, Dental, and Vision coverage
- Flexible Spending Account
- Health Reimbursement Account
- Free snacks and drinks
*As EQRx grows, please note that some of these are subject to change.
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50 Hampshire StreetTwo-hour street parking is available. There are also several parking garages in the surrounding area.
Cambridge, MA 02139