Job Description
About the position Responsibilities • Manage diagnostic clinical studies • Develop and manage the protocol, case report form, budget/contract negotiation and regulatory document management • Assist clinical sites with IRB submission/documentation, as needed • Setup and keep Diagnostica, their own remote clinical trial management system, up to date • Monitor clinical studies • Develop monitoring plans, identify issues, and resolve queries, ensure site regulatory binders are compliant • Manage site relationships by helping with study startup, answer questions during the study, ensure timely payments and close out activities Requirements • A minimum of 4 years' experience in the clinical research industry supporting clinical studies or clinical operations currently or recently • Prefer at least 1-2 years clinical research monitoring experience • Must have strong understanding of clinical trial regulatory and compliance processes • Understanding of regulations for FDA and Sponsor trial auditing • Strong ability to research data and identify issues or potential red flags in a study • Ability to learn quickly and expand knowledge into trial processes • Diagnostic clinical study experience or lab diagnostic experience preferred • Knowledge of accepted good clinical research practice (GCP) and procedures • Excellent organizational, time management, budget management, and problem-solving skills • Comfortable in a fast-paced small company environment • SOCRA CRA certification or willingness to apply for certification once hired Nice-to-haves • Experience with remote clinical trial management systems • Familiarity with budget management in clinical studies Benefits • Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability • Retirement savings plan • Service bonus and holiday pay plans (up to eight paid holidays per benefit year) • Transit spending account • Paid sick leave under applicable state or local plan Apply tot his job