Senior Clinical Project Associate

relaytherapeutics; Cambridge (MA); On-site; USD 69,000 - 99,000; Full time

Job summary

Relay Therapeutics is seeking a Senior Clinical Project Associate to support end-to-end clinical trial coordination, from site start-up to study closure. You will work with CROs and vendors, maintain trackers, review essential documents, and help prepare meeting materials.

Strong communication, multitasking, and attention to detail are essential in our fast-paced environment. You should have 2–3 years of clinical trial experience, familiarity with GCP/ICH guidelines, and proficiency in MS Office

Qualifications

• 2–3 years of clinical trial experience.
• Familiarity with GCP and ICH guidelines and application to trials.
• Motivated self-starter in a fast-paced, small company.
• Strong communication and public speaking skills.
• Proficient with MS Office including MS Project, Excel and PowerPoint.

Responsibilities

• Coordinate day-to-day clinical trial execution across sites, CROs and vendors.
• Support site start-up, participant enrollment, monitoring and drug supply planning.
• Define clinical supply logistics and ensure GCP and protocol compliance.

Skills

Clinical trial coordination

GCP/ICH guidelines

MS Office (Projects, Excel, PowerPoint

Tools

MS Project

Excel

PowerPoint

Job description

The Opportunity:

As Senior Clinical Project Associate, you will be accountable for providing clinical trial coordination support, along with implementing operational plans in accordance with regulatory guidelines and ICH/GCP standards. You will be an integrated member of the Relay Tx Clinical Development Operations team making key contributions to the execution of clinical trials that will translate Relay's innovative science into impactful medicines for patients.

Your Role:

You will support the day-to-day operations of clinical trial execution, with a focus on site start-up, study participant enrollment, clinical monitoring, drug supply planning, defining clinical supply logistics, GCP and protocol compliance, from the clinical sites, CROs and vendors.

You will coordinate with the CRO and the Relay Tx Clinical Operations Lead to support planning from study initiation through study closure.

You will maintain study trackers and provide metrics as needed.

You will review and contribute to key study documents including, but not limited to, informed consent forms, case report forms, and study plans.

You will assist with the preparation and distribution of meeting agendas and minutes as well as actively participate in team meetings providing updates on your key responsibilities.

You will help to ensure the Trial Master File is up-to-date and inspection ready.

You will support inspection readiness by collaborating with CROs and providing support to clinical sites to prepare for and respond to audit/inspection findings conducted by internal QA and external regulatory agencies.

You will actively participate in the development of department initiatives; contribute ideas to department initiatives that will make a difference to the efficiency and effectiveness of Clinical Operations.

Your Background:

You have 2-3 years of experience in clinical trial experience. CRO or Sponsor experience is strongly preferred.

You are familiar with GCP and ICH Guidelines and the application to the conduct of clinical trials

You are a motivated self-starter who is capable of flourishing in a fast-paced small company environment.

You are a creative problem-solver with excellent communication and public speaking skills.

You are familiar with MS Office products (MS Project, Excel and Power Point)

You have strong interpersonal and organizational skills, with a high degree of attention to detail.

You are pragmatic and able to manage multiple projects and needs effectively

Estimated Salary Range : [ $69,000 - $99,000 ].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.

About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.

Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!