Director of Clinical Trial Initiation
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
You will coordinate, guide and assist with all start up activities prior to site activation. You will provide country-level expertise and support to study start-up teams. You will assist the contracts and budgeting team with the completion and distribution of Confidential Disclosure Agreements (CDAs)/Clinical Trial Agreements (CTAs), as well as providing inter-mediation, as necessary, to support the execution of agreements with sites within their country of expertise. You will identify and build relationships with strategic partners, sites and investigators and participate in the identification and selection of sites and investigators, including national lead investigators, as necessary.
You will coordinate the distribution and collection of Feasibility Questionnaires (FQs) to sites in assigned countries and follow-up accordingly to ascertain interest and to meet study timelines. You will distribute and review site essential documents either directly or through coordination with assigned CRAs in specific countries. You will assist with the creation, translation (native speaker or sufficiently skilled in the local language(s) to translate / review translations), and review of regulatory documents specific to local and central Ethics Committee (EC) submission requirements. This role will assist with the creation, translation, and review of regulatory documents for Competent Authority (CA) clinical trial applications (CTA, or equivalent) and submissions or notifications to other regulatory agencies, as applicable. You will be responsible for the collection and maintenance of the current Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for the assigned countries.
You will ensure completeness and accuracy of Feasibility Questionnaires, CDAs, CVs and essential regulatory document from sites from study start-up phase until site initiation and perform timely and accurate data entry of study start up status and documents, regulatory documents and submission status of country/site information. You will localize Informed Consent Form(s) (ICF) in line with regulatory and health authority requirements and maintain information on ethics committee and competent authority meeting dates, costs, submission processes, and online systems. You will also maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation and track metrics and study start up timelines.
The Impact You Will Have
This is not your standard Trial Start-up position. We are doing things different 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.
Who You Are
- You have a bachelor’s degree.
- You have more than 5 years of experience in clinical research, preferably in Study Start Up.
- You have knowledge of GCP and a good understanding of the processes associated with clinical operations, study management and monitoring, and global regulatory requirements.
- You possess a strong skill set to synthesize and analyze data from various trials.
- 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, SOPs and systems.
- You have a working knowledge of GCP/ICH 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. What does EQRx stand for?
Are you ready to think differently and embrace the journey?
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