Clinical Research Navigator

1 day ago

Bethesda, Maryland, United States Guidehouse Full time
About the Role

We are seeking a highly skilled Clinical Research Navigator to join our team at Guidehouse. As a key member of our Clinical Trials Unit, you will play a critical role in supporting the development and implementation of clinical research protocols.

Key Responsibilities
  • Develop and review clinical research protocols and related documentation, ensuring accuracy, consistency, and completeness.
  • Prepare and submit regulatory documents, including IRB submissions and IND/IDE safety reports.
  • Collaborate with researchers, principal investigators, and other stakeholders to develop and implement clinical research protocols.
  • Coordinate with regulatory authorities and ensure compliance with relevant regulations and guidelines.
  • Develop and maintain regulatory binders and ensure up-to-date documentation for each trial.
  • Assist in the development of internal research proposals, abstract submissions, and manuscript drafts.
  • Work with the Clinical Trials Unit and NINDS staff to develop and implement standard operating procedures for protocol navigation and regulatory writing.
Requirements
  • Master's degree in a relevant field, such as health sciences, biology, or neuroscience.
  • At least 2 years of experience in a clinical trial or research setting, with a focus on regulatory affairs and protocol development.
  • Strong writing and communication skills, with experience in writing clinical research protocols and regulatory documents.
  • Proficiency in Clinical Trial Management Systems (CTMS) and Electronic Data Capture Systems.
  • Ability to work independently and collaboratively as part of a team.
Preferred Qualifications
  • PhD degree in a relevant field.
  • Certification in clinical research, such as ACRP-CP or CCRP.
  • Experience with regulatory compliance, IRB submissions, and on-site visits.
About Guidehouse

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. We are committed to creating a diverse and inclusive workplace that values and respects the contributions of all employees. We offer a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) retirement plan and tuition reimbursement. We are an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

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