Allied Health - Staff/Administrative, Staff/Administrative
The successful candidate for this position will join a team of professionals who together will support university clinical trial and surveillance research projects. 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; develop source documents, gather patient data and maintain patient records, assist with consenting, ensure compliance with regulatory and compliance audits; management and administration of study medications (IV, oral, injectable); maintain research drug inventories, collection and processing of blood and other human specimens; collection, compilation, documentation and analysis of clinical trial research data; submitting protocols to Institutional Review Board; assist department administrators with study financial management, including managing research billing. 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 college degree program in a health related science field; more than three years of related and progressively more responsible or expansive work experience with clinical trials including phlebotomy and processing of labs; budgeting experience and safety requirements; experience with blood borne pathogens; or an equivalent combination of education and experience; completion of required Institutional Review Board training and certification within the first 30 days of employment and certification as a Clinical Research Associate within the first three years of employment; possession of a valid vehicle operator's license.
A degree in a clinical field, health related science field, biological science or completion of an Allied Health degree such as an RN; 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 and biological substance shipping training; Knowledge in coagulation disorders including hemophilia, VWD, platelet disorders, and thrombophilia; good communication skills with attention to detail; working Knowledge and experience of specialized database including HRSA databases; working knowledge of Microsoft Office Suite; 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; 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. 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.
Equal Employment Opportunity Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, age, disability or protected veteran status.
Required Application Materials
Resume and Cover Letter
Normally 8-5 but may require some weekend and evening hours.
Description of End Date
This is an off-dated position funded for one year 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 and Eligibility Ends on 2/23/2021 at 11:55 PM
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