Remote - Clinical Trial Associate

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Associate

Posted 4 months ago
Job details

A highly reputable pharmaceutical corporation is currently hiring a Remote - Clinical Trial Associate.


Primary Responsibilities

  • Perform general administrative tasks to support team members with clinical trial execution, e.g., assist with the development and formatting of documents, review and reconciliation of study-specific information, etc.
  • Collect, disseminate, and/or track regulatory documents, as required
  • Assist with filing documents in the Trial Master File
  • Track and prepare study-specific information utilizing databases, spreadsheets, and other tools
  • Manage and track study-specific contracts and clinical study payments in applicable systems
  • Create and track purchase orders for clinical trial programs
  • Manage and track clinical and non-clinical supplies, including purchase and shipping
  • Assist with the development and distribution of site binders
  • Set-up and coordinate meetings, take and distribute meeting minutes
  • Participate in special projects, as assigned

May be responsible for the following activities:

  • Authorize investigational product release
  • Assist in the preparation of Investigator and Study Coordinator Meetings
  • Communication for defined tasks and tracking of information between the study team and specified vendors
  • Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs
  • Maintaining the Trial Master File (TMF) and assisting with site management, initiating the distribution, collection, handling, reviewing, tracking and archiving of essential documents throughout the lifecycle of clinical studies; this includes managing the filing indexes and maintaining current lists of correspondence; ensures completeness of, conducts regular audits of, organizes and archives clinical Trial Master File documents, including clinical study site documents, email correspondence, training materials and other study documents; participates in TMF or study audits as request and assists with responding to findings.
  • Maintains completion of company and study-specific trainings such as SOPs, policies, study plans and documents by due date
  • May participate and contribute to the implementation of process improvements to support study teams, department or the company (e.g. SOPs)
  • Assist with other duties and projects, as needed


QUALIFICATIONS:

  • Bachelor's Degree, or equivalent, in a biomedical, life science or related field of study, preferred
  • Minimum of 2+ years of clinical research experience with a pharmaceutical, biotechnology, or contract research organization (CRO).
  • Familiarity with GCPs, ICH guidelines and FDA regulations.
  • Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written.
  • Requires no previous clinical trial coordination and/or site management experience
  • Must be able to prioritize and manage a large volume of work and show attention to detail
  • Excellent communication and interpersonal skills are essential as the CTA interacts with many people of varying levels of responsibility for clinical trial programs
  • Must be able to write clearly and summarize information effectively
  • Must have the ability to build and maintain positive relationships with management and peers
  • Experienced using computer applications including spreadsheets, email, word-processing software and web-based systems

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Associate

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 16, 2024
Company Overview
Beacon Hill Staffing Group
Beacon Hill Staffing Group

Current Openings: 0

Beacon Hill Staffing Group was founded to set a new standard in search, career placement and flexible staffing. Our niche brands provide direct hire, executive search, temporary staffing, contract consulting and temp/contract-to-hire solutions to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs. Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Government Services, Beacon Hill Legal, Beacon Hill Life Sciences, Beacon Hill Solutions and Beacon Hill Technologies by visiting www.beaconhillstaffing.com. We look forward to working with you.
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