Rolla, MO, USA
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 compliance with applicable Federal regulations and institutional policies and procedures, including appropriately documenting all research processes, obtaining IRB approval, 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.
Trains individuals involved in the conduct of the study around issues relating to protocol requirements, schedule of visits, and execution of research plan. Maintains documentation of training.
Maintains adequate inventory of study supplies. If handling investigation drugs/devices, follows the sponsor protocol and/or institutional policy on Drug/Device Accountability.
Bachelor’s Degree from an accredited scientific or health related program required or Associate’s Degree from an accredited nursing program required.
Bachelors: Minimum of one (1) year of clinical research experience required or Associates Nursing: Minimum of two (2) years of clinical research experience required.
Clinical Research Coordinator certification (ACRP or CCRP) within one (1) year of eligibility required.
Considerable mental concentration for sustained periods of time with attention to detail of paramount importance. Pressures at times, accuracy, and interruptions. Must handle confidential material. Standing, walking, reaching, bending, and stooping. Vision and hearing must be good. Must have finger dexterity and complete use of hands and arms. Computer proficiency required. Must have excellent customer service skills and patience in dealing with difficult situations.
Minimal physical discomfort. Frequent exposure to communicable disease via blood and body fluids. Frequent exposure to communicable diseases, radiation, anti-neoplastic agents and hostile persons at times. Works with sharps and other potentially biohazardous material. Ability to function under stress.