Clinical Protocol Coordinator US132 Guidehouse Digital LLC
Overview
The Clinical Protocol Coordinator supports operational objectives of the National Cancer Institute within the Division of Cancer Treatment and Diagnosis. This full-time role based in Bethesda MD offers telework eligibility and requires a Federal or DoD public trust. Responsibilities include managing audits coordinating with auditing units nursing staff and medical records personnel providing technical support to researchers and preparing SOPs.
What You'll Do18
- 1Manage audit activities and collate responses while conducting quality assurance activities for regulatory audits by FDA NIH and pharmaceutical sponsors
- 2Provide technical support for protocol coordination patient scheduling registration and inquiry resolution
- 3Coordinate with IRB administrators to collect review and submit regulatory documentation through NIH Protocol Tracking and Management System
- 4Prepare SOPs related to audits and clinical research attend multicenter site calls and draft meeting notes
- 5Respond to data and regulatory queries from Theradex and collaborate with nursing staff and data managers on written responses
- 6Assist with preparation of regulatory documents for FDA CTEP IRB OPRR and drug sponsors
- 7Update regulatory binders and maintain accurate study records
- 8Support researchers with protocol development assembly of documentation and creation of protocol schemas patient calendars and informed consent forms
- 9Develop internal research proposals abstracts posters and manuscripts
- 10Create protocol schemas operational procedures and study-related SOPs
- 11Collect organize and maintain study documentation including investigator qualifications trial logs safety reports and correspondence
- 12Write edit and maintain study protocols amendments reports and regulatory submissions
- 13Prepare and submit safety reports annual reports amendments and regulatory correspondence
- 14Maintain data files across multiple software systems and communication platforms
- 15Perform data entry cleanup database queries descriptive statistics and univariate analyses
- 16Coordinate recruitment scheduling travel and admission of research participants
- 17Communicate with IRB personnel and NIH Clinical Center staff regarding protocol approvals
- 18Capture and fulfill all labor category requirements as specified by the customer
Requirements16
- 15+ years building ETL pipelines with Spark and Airflow
- 2Minimum of TEN (10) years supporting clinical research clinical trials or protocol coordination
- 3Experience preparing maintaining and submitting regulatory documentation
- 4Knowledge of quality assurance processes and regulatory audit preparation
- 5Ability to obtain and maintain a Federal or DoD public trust
- 6Familiarity with Clinical Trial Management Systems (CTMS)
- 7Proficiency using Electronic Medical Record (EMR) systems
- 8Strong analytical organizational and time management skills
- 9Strong written and verbal communication skills
- 10Ability to work independently and collaboratively in a multidisciplinary research environment
- 11Working knowledge of Electronic Data Capture (EDC) systems
- 12Background in clinical trials quality assurance and monitoring
- 13Prior support for NIH NCI DCTD or other federal clinical research programs
- 14Ability to perform descriptive statistical analyses and manage study databases
- 15Demonstrated ability to coordinate multicenter clinical research activities
- 16Proficiency with Microsoft Office Suite
Salary Insight
$130 - $216k per year
Location
Required Skills
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