Clinical Trial Registration Coordinator (6-Month Contract)
Clinical Trial Registration Coordinator (6-Month Contract)
This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$25.00/hr - $35.00/hr
The Clinical Trial Registration Coordinator I at Cancer Center plays a critical role in ensuring compliance with federal regulations related to clinical trial registration and reporting. Working within the Office of Data Quality (ODQ), this position is responsible for managing and maintaining clinical trial records in databases such as ClinicalTrials.gov and the Clinical Trials Reporting Program (CTRP). The role involves interpreting complex regulatory requirements, supporting investigators and research teams, and ensuring DF/HCC’s continued eligibility for federal funding through accurate and timely trial registration and updates.
Compensation:
* $25/hr to $35/hr
* Bachelor’s degree with scientific specialty or other relevant major preferred or equivalent work experience.
* At least 1 year of direct regulatory experience in a medical or complex regulatory setting; familiarity with clinical trial regulations is strongly preferred.
* Experience with ClinicalTrials.gov and CTRP
* Ability to work independently and navigate software and computer systems remotely.
* CRC or MA are background
Duties:
The primary role of the Clinical Trial Registration Coordinator I is to interpret NCI, NIH, FDA, ICMJE and other federal requirements along with policies to make independent decisions regarding federal reporting human subject research projects. These decisions are critical for our compliance with federal law and maintaining the NCI funding of the cancer center.
* Oversees registration, maintenance, and compliance of Clinicaltrials.gov records
* Acts as Clinicaltrials.gov PRS Administrator.
* Reviews new protocols and identifies which protocols require registration in accordance with FDAAA-801, International Committee of Medical Journal Editors (ICJME) or the Sunshine Act.
* Creates initial Clinicaltrials.gov registration for applicable trials.
* Manages Clinicaltrials.gov accounts for investigators and research teams.
* Runs routine reports to review and monitor Clinicaltrials.gov records for compliance. Notifies investigators of non-compliance
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Contract
Job function
* Job function
Research
* Industries
Hospitals and Health Care
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