We believe it’s possible to have a profound impact on bending the cost curve in healthcare by building a pipeline of innovative medicines and bringing them to market at dramatically lower prices.Robert Forrester CXO
Lead CRA / Clinical Team Lead
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.
Who We Are
We're a new kind of biotech, one with a bold mission to bring innovative new medicines at dramatically lower costs.
What You’ll Do
The Lead Clinical Research Associate (CRA)/Clinical Team Lead will join clinical operations as part of the core study team working together with the Clinical Project Manager to oversee site management and monitoring activities. You are a leader who can assess clinical trial site performance, adequacy of monitoring activities and proactively identify and communicate site management and monitoring risks to the Project Manager. You will work as the solo CRA on a study team or oversee one or more CRAs while maintaining a small number of sites to monitor.
You will establish and maintain effective project/clinical site communications, develop and manage site management and monitoring plans, proactively identify gaps in processes/plans and assessment for process improvements and efficiencies. You will 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, 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 direct and indirect assessment of site performance for single or multiple studies through monitoring and monitoring oversight. This will include the conduct of pre-study, initiation, monitoring and close-out visits, completion and/or review of monitoring trip reports and letters. 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 verify electronic case report form data against written and electronic source documents. You will document accountability, stability, and storage conditions of clinical trial materials. You will ensure the investigator site file remains inspection ready including review, collection and maintenance of the sponsor trial master file.
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 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 Lead Clinical Research Associate (CRA)/Clinical Team Lead will also assist the Clinical Project Manager with vendor selection, oversight and management, study budget projections and tracking and maintenance and monitoring of project timelines. The Lead Clinical Research Associate(CRA)/Clinical Team Lead may also be responsible for leading CRA or other project related meetings.
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 proven ability of strong decision making and problem-solving skills.
- You have experience mentoring CRAs// Junior CRAs.
- You have a bachelor’s degree or are a 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 Harmonization 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 can participate and work effectively on multiple cross-functional teams.
- 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 build a sustainable pipeline of excellent drugs at much lower prices?
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.
Stay in the Loop
Follow on social.
50 Hampshire StreetTwo-hour street parking is available. There are also several parking garages in the surrounding area.
Cambridge, MA 02139