Clinical Project Coordinator

2 weeks ago

Raleigh, North Carolina, United States Catalyst Clinical Research LLC Full time
Job Overview

As a Clinical Project Coordinator, you will play a vital supporting role to the Project Manager (PM). Your responsibilities will encompass assisting in various tasks for one or more clinical studies, including the preparation of study documentation, monitoring all facets of the study/studies, and organizing meeting materials along with minutes. You will be involved in all phases of clinical studies from initiation to conclusion, collaborating with both internal and external teams to meet clinical study objectives.

Key Responsibilities:

  • Support the delivery of all operational elements of assigned clinical studies from protocol development through to the final clinical report.
  • Assist the PM in executing trials efficiently and with high quality while maintaining cost-effectiveness.
  • Work closely with the PM and project team to identify and resolve issues that may adversely affect the integrity of the clinical study.
  • Continuously seek ways to enhance collaboration, efficiency, and excellence in achieving deliverables.

Specific Duties Include:

  • Facilitate communication and integration of study parameters among all stakeholders, including subcontractors, strategic partners, internal teams, and sponsors.
  • Develop and implement communication and monitoring strategies, ensuring project team training on these plans.
  • Provide input and coordination at the trial level, including feasibility assessments, recruitment strategies, site selection, and study material design.
  • Maintain up-to-date knowledge of ICH and GCP regulations and guidelines relevant to the studies conducted by the company.
  • Oversee the creation of all study startup materials necessary for operational and regulatory compliance in clinical trials.
  • Collaborate with the PM and management to develop investigator contracts, budgets, invoicing systems, and payment schedules.
  • Ensure timely and accurate payments to investigators based on requests from field monitors, under the PM's guidance.
  • Partner with the PM and Data Management team to create and review the data management plan, including edit specifications and CRF development.
  • Conduct User Acceptance Testing (UAT) of the clinical database for assigned studies.
  • Assist the PM in preparing meeting agendas and minutes for various discussions, including sponsor team meetings and site meetings.
  • Develop the Clinical Trial Management System (CTMS) tracker in collaboration with the PM and project team to ensure comprehensive project plan documentation.
  • Coordinate with the PM and Clinical Trial Assistant (CTA) to manage the delivery of clinical supplies and ensure timely drug shipments.
  • Revise site recruitment strategies as necessary to meet project goals.
  • Work with the PM and CTA to ensure all required study materials are provided to study sites.
  • Collaborate closely with the data management team to facilitate smooth data retrieval, posting, and corrections while adhering to GCP and company SOPs.
  • Conduct quality reviews of project-level electronic Trial Master Files (eTMF) as per the reference model for assigned studies.

Qualifications:

  • A minimum of a BS/BA in a biomedical field and 3 years of experience in the clinical research industry, or at least 8 years of relevant experience.
  • Preferred experience in study management or coordination.
  • Proven ability to work effectively with multiple partners, vendors, and outsourcing teams.
  • Excellent verbal and written communication skills in all professional interactions.
  • Proficiency in the complete MS Office suite (Word, Excel, Access) and MS Project.
  • Strong analytical and problem-solving skills.
  • This position can be office-based or fully remote.

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