Clinical Research Protocol Specialist

2 weeks ago


Rockville, Maryland, United States PriceSenz Full time
Job Overview

Position Title: Clinical Protocol Coordinator

Company: PriceSenz

Location: Rockville, MD

Weekly Commitment: Full-Time, 30-40 hours per week

Position Summary:

The Clinical Protocol Coordinator will play a vital role in the Translational Immunopsychiatry Unit (TIU) at PriceSenz. This position is ideal for a dedicated, detail-oriented individual with exceptional organizational and communication skills. The Coordinator will be responsible for overseeing clinical and biospecimen research activities, contributing to the advancement of the Autoimmune Brain Disorders Program (ABDP).

Key Responsibilities:

  1. Research Coordination: Facilitate the development, implementation, and maintenance of clinical research data files and materials.
  2. Protocol Management: Prepare and submit new IRB protocols, ensuring compliance with regulatory standards.
  3. Data Collection: Assist in the collection and analysis of research data, ensuring timely submission of study and regulatory forms.
  4. Quality Assurance: Monitor recruitment and enrollment, prepare reports, and coordinate responses to audits.
  5. Collaboration: Work closely with clinical staff to support the development of forms and questionnaires, ensuring adherence to NIH policies.
  6. Training and Mentorship: Provide training to new research coordinators and support staff in Good Clinical Practices.

Qualifications:

Education: Bachelor's degree in a relevant field.

Skills:

  • Experience in managing clinical trial materials and coordinating project meetings.
  • Proficiency in biomedical research informatics systems.
  • Strong understanding of regulatory compliance and ethical standards in clinical research.

Additional Information:

The Clinical Protocol Coordinator will also be responsible for developing and implementing systems for data management and ensuring the quality of clinical research efforts. This role requires a proactive approach to problem-solving and the ability to work collaboratively within a dynamic research environment.



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