The successful candidate for this position will join a team of professionals who together will support university clinical trial research operations. This individual will coordinate and participate in the support and administration of clinical trial research studies conducted by principal investigator(s) from departments, on projects including, but not limited to, grant funded and/or industry sponsored clinical trial research conducted on site or affiliated sites; coordinate and participate in a variety of complex activities including the screening and recruitment, enrollment and ongoing care of study subjects per protocol requirements; management and administration of study medications (IV, oral, injectable); collection and processing of blood and other human specimens; collection, compilation, documentation and analysis of clinical trial research data; assist department administrators with study financial management. Coordinate and participate in the initiation of new clinical trial research studies; monitoring, completion, and reporting of moderately complex clinical studies in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (ICH-GCP).
Unit Specific Education/Experience/Skills
Knowledge equivalent to that which normally would be acquired by completing a four-year degree in a clinical field, health related science field, biological science or completion of an Allied Health degree such as an RN; more than three years of related and progressively more responsible or expansive work experience with clinical trial research including phlebotomy and processing of labs; safety requirements; experience with blood borne pathogens; or an equivalent combination education and experience; completion of required Institutional Review Board training and certification within the first 30 days of employment and certification as a Certified Clinical Research Coordinator (CCRC) through Association of Clinical Research Professionals (ACRP) or as a Certified Clinical Research Professional (CCRP) through Society of Clinical Research Associates (SOCRA) or equivalent research certification within the first three years of employment; possession of a valid vehicle operator's license.
Experience in clinical trial planning and study start-up procedures and study feasibility analysis, study budget and costing, protocol review for inclusion/exclusion criteria, study population assessment, and project logistics; experience with phlebotomy, placement and management of intravenous sets, and administration of IV medications; development of recruitment plans and retention strategies; knowledge of HIPAA, Good Clinical Practice Guidelines (ICH-GCP), bloodborne pathogen guidelines; ability to work a flexible schedule including some evenings and weekends; ability to compassionately interact with study subject and representatives/caregivers with respect to difficult problems concerning mental and physical issues.; experience in data collection and management, including creation of study source documentation, working with electronic data collections systems and electronic medical records, and creation of reports for study sponsors and regulatory agencies.
Ability to work independently with minimal supervision, with frequent interruptions, and ability to communicate well under difficult situations; experience in study administration including regulatory document management (IRB submissions, SAE reporting), provision of assistance to the Principal Investigator in clinical and research procedures, as required by study protocol, administration of informed consent to study subjects, phlebotomy and basic clinical laboratory procedures for processing of human specimens.
Required Application Materials
8-5 but may have some evenings and weekends. Unit does offer some flexible work arrangement schedules.
Description of End Date
This is an off-dated position funded for two years from date of hire, with possible extension contingent upon funding renewal.
Summary of Health Risks
Exposure to human blood, serum, tissue and other body fluids; and materials covered under Universal Precautions
TB risk or work within 3 feet of human patients in a health care setting
Bidding eligibility ends on 3/17/2020 at 11:55 PM
Internal Number: 640711
About Michigan State University
Spartans work every day to advance the common good in uncommon ways.Together, we tackle some of the world?s toughest problems to find solutions that make life better?from alternative energy to better food safety to breakthrough medical and environmental applications achieved through rare isotope research.We teach. We explore and we discover. We collaborate and lead. We innovate, inspire, and empower. We achieve our potential and create circumstances that help our students and others achieve theirs.We're good at it, and we've been at it for more than 150 years.The nation?s pioneer land-grant university, MSU began as a bold experiment that democratized higher education and helped bring science and innovation into everyday life. The revolutionary concept became a model for the nation.Today, MSU is one of the top research universities in the world?on one of the biggest, greenest campuses in the nation. Home to nationally ranked and recognized academic, residential college, and service-learning programs, we?re a diverse community of dedicated students and scholars, athletes and artists, scientists and leaders.In ways both practical and profound, we work to create a stronger, more sustainable, and more hopeful future for all.