Job Summary:
TheClinical Research Associate I (CRA I) will join a team of experienced associates and manage various research trials, including first in human through phase 3 trials. The role will be expected to manage 2-3 studies simultaneously. The will ensure compliance with FDA guidelines and follow GCP for all managed studies. TheCRA I will interact daily with clinicians, sponsors, IRB, regulatory agencies and other research professionals. This is a subject / patient facing role, the candidate needs the ability to communicate directly with study volunteers, collecting detailed clinical information and communicating that to the study team. TheCRA I will be responsible for all aspects of the trial conduct including; IRB submission, regulatory documents, training staff, overseeing enrollment of appropriate study subjects, creation and completion of source documents, database entry and query resolution. TheCRA I will be the point person on assigned clinical trials and flexible availability is expected. This role is also the key contact for study sponsors / collaborators; therefore, a high level of professionalism and communication skills are required. This role will be expected to prepare for a national certification (SoCRA) exam after 2 years of full-time employment. Minimum Qualifications: A bachelors degree and 2 years of related experiance or a equivalent combination of education and experiance.Ability to function in a professional environment, that requires a high attention to detail and exemplary. Preferred Qualifications: Clinical skills including phlebotomy, ability to take and record accurate vital signs, obtain EKG tracings, and general medical terminology will be preferred. Work Days: Monday - Friday 8am - 4:30pm. Occasional evenings and weekends Message to Applicants: Salary range-$60,406-$65,000 RecruitmentOffice: Human Resources...translational scientific rationale is clearly communicated and captured in relevant documents and reports+ Partner with Nonclinical/Toxicology to evaluate potential or observed on-target safety/tolerability signals for new targets**External Engagement and Collaboration**...
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