Job Summary:
The Clinical Research Associate II (CRA II)will join a team of experienced coordinators and manage various research trials, including first in human through phase 3 trials. The role will be expected to manage 4 or more studies simultaneously. The CRA II will ensure compliance with FDA guidelines and follow GCP for all managed studies. The CRA II 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. The CRA II 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. This position 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 maintain a national certification (SoCRA or ACRP). Minimum Qualifications: ABachelor's degree and 3 years related experience or equivalent combination of education and experience.Ability to function in a professional environment, that requires a high attention to detail and exemplary communication and organizational skills. Fluent with Microsoft Office products including excel. Experience with clinical documentation and HIPAA guidelines is required. Preferred Qualifications: Clinical Research Associate Certification (SOCRA or ACRP) OR eligibility to sit for exam for certification. Clinical skills including phlebotomy, ability to take and record accurate vital signs, obtain EKG tracings, and general medical terminology. Work Days: Monday - Friday 8am - 4:30pm. Occasional evenings and weekends. Message to Applicants: Salary Range:$65,000-$80,000 RecruitmentOffice: Human Resources...distinctive path. We introduced untreated and raw denim to the fashion world, elevating the fabric into a mature and sophisticated... ...Leap Perks: ~ Bonus Eligible ~ AllOne Health - Employee Assistance Programs ~401K ~ Accrued PTO: ~ Part-Time hourly employees...
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