Remote - Clinical Trial Associate
Remote - Clinical Trial Associate
Beacon Hill
United States
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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
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Research, Quality Assurance, and Project Management -
Industries
Research Services, Biotechnology Research, and Pharmaceutical Manufacturing
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