Clinical Research Project Associate
The American College of Radiology (www.ACR.org), a professional association for radiologists, is a world leader in radiology clinical research. The Center for Research and Innovation located in Philadelphia, administers research for numerous commercial and grant funded entities. Cancer research efforts include studies performed through the prestigious RTOG Foundation (www.RTOG.org), commercial sponsored research awarded to ACR for diagnostic imaging, and a number of NCI awards to, NRG Oncology Group (www.NRGOncology.org), IROC Group (www.IROCQA.org), and ECOG-ACRIN (www.ECOG-ACRIN.org). In addition, ACR CRI conducts research in cardiology, neurology, pediatrics, and other body systems and also has led validation efforts for advancing new software and Artificial Intelligence algorithms.
To support these strategic objectives, ACR is seeking a Clinical Research Project Associate for our Protocol Development & Regulatory Compliance department. Telecommuting available upon successful completion of new employee orientation/training period.
Interacts with IRB vendors, ACR Leadership, and protocol teams for IRB submission and response letters.
Conducts quality assurance reviews for regulatory site documents prior to site activation.
Assists with processing site requests for IRB closures.
Provides back-up support for Serious Adverse Event Specialist to perform initial safety review form the National Cancer Institute (NCI)/Rave databases and triage of adverse events to determine seriousness, expectedness and priority.
Conducts reviews of regulatory audit files
Provides back up support for protocol development (i.e. preparing study materials), when applicable
Reviews consent forms and regulatory files for sites, including international member sites
Supports global regulatory clinical trial submissions, registrations and filings (i.e. Clinical Trial Applications to Health Canada); including writing, formatting, compiling and maintaining supporting documentation/technical files for studies.
Assists with the preparation and submission of regulatory documents to the FDA for new trials and amendments; Investigational New Drug Applications (IND), IND exemptions, annual reports
Accesses clinical trial databases (OPEN & RSS), and other databases for necessary information involved in patient registration, study information, accrual, and audit/monitoring information.
Provides support to Regulatory Manager to schedule meetings, conference calls, etc.
Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents. (e.g. FDA, GCP, ICH, NIH, NCI, OHRP, etc.)
Assists the Protocol Development & Regulatory Compliance Department with maintenance of SOPs, website/databases, and manuals.
Qualified candidates will possess the following:
4+ years of related experience
BS degree preferred
Familiarity with FDA and IRB requirements
Excellent written and verbal communication skills
Superior writing and editing skills
If you would like to put your experience to great use in a professional team-oriented environment, please apply online. To learn more about ACR's rewarding employee experience, culture, and benefits, visit: https://www.acr.org/About-ACR/Work-With-Us
ACR offers a rewarding employee experience: innovative culture, professional growth potential, competitive compensation and an exceptional benefits package, including a defined contribution pension plan, 403(b); generous paid time off package; insurance plans with the leading providers; flexible spending; tuition reimbursement; training opportunities; and wellness reimbursement.
American College Of Radiology