Phelps County Regional Medical Center Clinical Research Assistant in Rolla, Missouri
The Clinical Research Assistant is a specialized research professional who supports the daily activities of clinical research studies with an emphasis on screening, enrollment, and monitoring of study participants.
Essential Duties and Responsibilities
· Enrolls patients into clinical research studies by screening for eligibility, obtaining informed consent, registering participants into research databases, completing Case Report Forms, coordinating study procedures, and monitoring participant.
· Ensures research compliance with applicable Federal regulations and institutional policies and procedures, including appropriately documenting all research processes, requesting IRB approval for research projects, and maintaining ethical, legal, and HIPAA requirements.
· Ensures appropriate billing for study-specific procedures by registering patients into research accounts and reviewing related billing.
· Initiates research projects by collecting necessary documents, reviewing study protocol, seeking IRB approval, and coordinating with the Research Department.
· Closes research projects by collecting necessary documents, arranging secure storage of study documents according to institutional and sponsor policy, and assisting research team with project reporting and monitoring requirements.
· Facilitates monitoring and auditing visits by notifying appropriate institutional officials of external audits by the FDA and funding sponsors, responding to any audit findings, and implementing approved recommendations.
· Bachelor's Degree from an accredited scientific or health related program required.
Minimum Work Experience
· Minimum of six (6) months of clinical research experience required; OR
· Minimum of one (1) year of research experience required.
· Clinical Research Coordinator certification (ACRP or CCRP) within one (1) year of eligibility preferred.