Senior Clinical Project Associate

Relay Therapeutics; Cambridge (MA); Vor Ort; USD 69.000 - 99.000; Vollzeit

Zusammenfassung

Relay Therapeutics is seeking a Senior Clinical Project Associate to coordinate clinical trial activities and ensure compliance with GCP and ICH guidelines. You will support site start-up, patient enrollment, monitoring, and drug supply planning while collaborating with CROs and the Relay Tx Clinical Operations Lead.

You will maintain trackers, review key study documents, and help prepare meeting materials.

Qualifikationen

• 2–3 years of clinical trial experience (CRO or Sponsor preferred).
• Familiar with GCP and ICH Guidelines and their application to trials.
• Proficient with MS Office: Word, Excel, PowerPoint; ability to create and maintain trackers.

Aufgaben

• Support day-to-day operations of clinical trial execution with focus on site start-up, enrollment, monitoring, and supply planning.
• Coordinate with CRO and Clinical Operations Lead to support planning from study initiation through closure.
• Maintain study trackers and provide metrics as needed.
• Review and contribute to study documents including informed consent forms, CRFs, and study plans.
• Prepare and distribute meeting agendas and minutes; provide updates in team meetings.

Kenntnisse

Clinical trial experience

GCP & ICH knowledge

MS Office proficiency

Public speaking

Organizational skills

Tools

MS Project

Excel

PowerPoint

Jobbeschreibung

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 partsfearlessandrelentless, 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!

As set forth in Relay Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.