Remote - Clinical Trial Associate

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