Clinical Trial Associate_KS Job at Resource Logistics, Inc.

Resource Logistics, Inc. Massachusetts

Job Title: Clinical Trial Associate

Job Location: Lexington, MA 02421

Job Duration: 3+ months

**If candidate wants to be considered for a FTE role, they must be HYBRID. If the candidate wants to work as contractor only for a year, they have the flexibility of working remote**

JOB DETAILS:

Description:

PURPOSE
We are seeking a highly organized and detail oriented Clinical Trial Associate (CTA) to assist with the execution of clinical trials.

RELATIONSHIP
This position reports to the Associate Director/Director Clinical Operations

ESSENTIAL FUNCTIONS

  • Support the clinical development team in the overall management of studies, including planning, execution and closeout of outsourced clinical trials.
  • Assist the Clinical Project Manager in site management activities. This could include review of monitoring report, tracking of site visits, and communication with monitors and sites.
  • Work closely with clinical project managers to assist with preparation of all external and internal documentation for assigned trials to ensure it’s completed in accordance with GCP regulatory requirements and consistent with the study protocol.
  • Assist in the creation of and distribution of study materials and communications to KOLs, CROs and other external vendors
  • Organize and prepare study files related to study tracking and reporting and submit them to the Trial Master File within established guidelines, maintain up-to-date documentation for all study sites globally.
  • Assist the project team with planning, preparation and possible on-site support of investigator’s meetings.
  • Support invoice and budget activities.

PHYSICAL REQUIREMENTS
Approximately 0 – 20% overnight national and international travel

QUALIFICATIONS

  • Bachelor’s degree required, preferably in a science or healthcare related discipline
  • A minimum of 4 years of experience supporting clinical studies at a pharmaceutical, biotechnology company or a CRO
  • Working knowledge of ICH GCP regulations and clinical protocols
  • Strong interpersonal, organizational and multi-tasking skills
  • Sound analytical and problem-solving skills; ability to act with a consistent sense of urgency

Job Types: Full-time, Contract

Salary: $40.00 - $55.00 per hour

Benefits:

  • 401(k) matching

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

COVID-19 considerations:
Candidate has to be vaccinated and taken booster

Education:

  • Bachelor's (Required)

Experience:

  • supporting clinical studies: 4 years (Required)
  • ICH GCP: 4 years (Required)
  • clinical protocols: 3 years (Required)

Work Location: Remote




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