Clinical Research Coordinator

1 day ago


Emelle Alabama, United States Pharmaceutical Research Associates, Inc Full time
About the Role

We are seeking a highly skilled and detail-oriented Clinical Research Coordinator to join our team at Pharmaceutical Research Associates, Inc. As a key member of our clinical research team, you will be responsible for ensuring the smooth execution of clinical trials.

Key Responsibilities
  • Enter data into Clinical Trial Management Software (CTMS) and generate reports as required.
  • Assist Clinical Research Associates with various clinical study-related activities, including:
    • Supporting Institutional Review Board submissions and document preparation.
    • Coordinating site and study training.
    • Preparing site training and study initiation materials.
    • Creating and maintaining study binders.
  • Contact and coordinate study participant recruitment and enrollment for internal trials.
  • Initiate, coordinate, and manage activities associated with external patient trials and focus group meetings.
  • Conduct quality audits to ensure compliance with US or international regulations.
  • Maintain traceability and accountability of study devices.
  • Assist with device labeling, modified product process, set-up, and shipments.
  • Manage return and disposition of study equipment.
  • Manage Purchase Orders (POs) to facilitate study payments to sites and vendors.
  • Data Entry and Validation.
  • User Assessment Testing (UAT) of Electronic Data Capture (EDC) system.
  • Initiate and track requests for legal agreements.
  • Support the timely and accurate compilation of study data and reports.
Requirements
  • Bachelor's degree in biological sciences or a related field, or RN, or 5+ years' experience as a clinical research coordinator.
  • Work experience in life science or medically related field.
  • Prior experience providing administrative support in a clinical trial or data management setting.
  • Awareness and working knowledge of applicable clinical research regulatory requirements, such as good clinical practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
  • Knowledge and experience in budgeting, accounting, and contracting is preferred.
  • Self-motivated individual able to manage multiple tasks and priorities in an efficient manner.
  • Ability to work independently without direct supervision as well as in a team environment.
  • Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
  • Strong written and verbal communication skills in English.
  • Effective time management, planning, and organizational skills.
  • Attention to detail and accuracy in work.
  • Strong problem-solving skills and proactive attitude.
  • Fluency in Dutch and English.
What We Offer

We offer a competitive salary and a range of benefits, including various annual leave entitlements, health insurance, retirement planning, and flexible country-specific optional benefits.

We are committed to providing an inclusive and accessible environment for all candidates and employees. We welcome applications from diverse candidates and are an equal opportunities employer.



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