The successful candidate for this position will join a team of professionals who together will support the department clinical trial operations. Participate with the principal investigator in the development of plans, protocols and budgets for clinical research studies. Assess study clinical and financial feasibility including study population assessments, staffing and facility requirements, study logistics and budgets (ROI). Manage and coordinate clinical trial research studies in support of a supervising principal investigator. Develop guidelines and procedures for electronic data capture, electronic medical record access, and study data collection; coordinate and implement procedures to collect data from study participant charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation; create a variety of reports, documents and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes to assist in the ongoing monitoring and evaluation of the clinical research project's progress; ensure compliance with protocol guidelines and requirements of regulatory agencies; identify inconsistencies, recommend and execute corrective actions as appropriate. Coordinate development of clinical trial budget to determine overall feasibility of individual clinical trials. Gather necessary data related to staffing, support services and trial management costs.
Unit Specific Education/Experience/Skills
Knowledge equivalent to that which normally would be acquired through a four year college degree program in a clinical field such as health or biological science and a minimum of one to three years of related and progressively more responsible or expansive work experience in clinical and/or research; OR the job requires completion of an associate’s degree with clinical research coursework or an Allied Health degree and three to five years of related and progressively more responsible or expansive work experience in clinical and/or research; or an equivalent combination of education and experience. The job requires completion of required Institutional Review Board (IRB) training and certification within the first 30 days of employment.
Valid driver’s license.
Bachelor’s degree in health science field such as biology, micro- biology, chemistry, nursing. Three (3) or more years of 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 collecting, processing and mailing human specimen blood, sputum, other) 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 (GCP), bloodborne pathogen guidelines, Institutional Review Board policy/procedure, Compliance planning and reporting; ability to work a flexible schedule including some evenings; ability to compassionately interact with study subjects and representatives/caregivers with respect to difficult problems concerning mental and physical issues.
Institutional Review Board certified (or certification within 30 days of employ); Clinical Research Associate certification (or certification within 6 months of employ). Certified specialist in oncology and/or oncology research. Two (2) or more years in cancer research. Ability to work independently while communicating regularly with clinical trial team, investigator and sponsors progress on trial goals and objectives.
Required Application Materials
Cover letter, resume and 3 references regarding work experience and history
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 and Eligibility Ends on 8/4/2020 at 11:55 PM
Internal Number: 664388
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.