Clinical Protocol Coordinator

2 weeks ago

Rockville, Maryland, United States Cape Fox Shared Services Full time
Job Title: Clinical Protocol Coordinator

Cape Fox Shared Services is seeking a highly skilled and detail-oriented Clinical Protocol Coordinator to join our team. As a Clinical Protocol Coordinator, you will play a critical role in the development, implementation, and management of clinical trials.

Key Responsibilities:
  • Develop and maintain clinical trial protocols, informed consent forms, and other related documents.
  • Collaborate with investigators, research staff, and other stakeholders to ensure compliance with regulatory requirements and study protocols.
  • Conduct site initiation visits, monitor study progress, and ensure timely completion of study milestones.
  • Manage and maintain accurate and up-to-date records of study data, including participant information, study procedures, and adverse event reports.
  • Develop and implement quality control measures to ensure data integrity and accuracy.
  • Communicate effectively with study teams, investigators, and other stakeholders to ensure seamless study execution.
  • Participate in study team meetings, protocol development meetings, and other relevant meetings to ensure timely completion of study milestones.
  • Develop and maintain training plans and materials for study staff and investigators.
  • Ensure compliance with regulatory requirements, including FDA and IRB regulations.
Requirements:
  • Bachelor's degree in a life science or related field.
  • Minimum 2 years of experience in clinical research, including experience with clinical trial protocols, informed consent forms, and other related documents.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong organizational and time management skills.
  • Ability to maintain accurate and up-to-date records.
  • Knowledge of regulatory requirements, including FDA and IRB regulations.
Preferred Qualifications:
  • Master's degree in a life science or related field.
  • Experience with electronic data capture systems and clinical trial management software.
  • Certification in clinical research, such as CCRA or CCRP.

Cape Fox Shared Services offers a competitive salary and benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.

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