Job DescriptionNexGen Research is looking to hire a Part-time, onsite Clinical Research Coordinator (CRC). Must have prior clinical research experience, and desire to work directly with patients. The CRC will support various parts of the study including patient recruitment and scheduling, pre-screening, patient retention calls, data entry and uploads, and query resolution. The CRC must be willing to work a minimum of 20 hours per week and be flexible as needed. Position has potential to transition into Full-time. Certification, such as an RN, LPN, MA, phlebotomy, or similar, is a plus.Clinical Research Coordinator ResponsibilitiesManaging elements of clinical study while following ICH/GCP guidelines; and sites SOPs.Managing start-up activities, day to day management of a study and study closure.Support various parts of the study including patient recruitment, pre-screening, data entry and management, source document uploads, query resolution, scheduling patient appointments, e-diary compliance and patient retention callsRecruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects rights through institutional IRB, federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocateAssists in the recruitment plan; completes screening sheets and recruitment logs Ensures that the subject meets inclusion/exclusion criteria; alerts the investigator when the subjects safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.Chart review and phone screening (via EMR)Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; Adheres to departmental quality control guidelines.Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRFs are completed prior to monitoring visitsPerforms research activities as outlined in the protocol assigned to him/her.Collection of study data and entering data into EDC (as well as keep EDC up to date)Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etcPrepares and processes human specimens according to skill level and certifications.Maintains regulatory binder and documents.Performs other duties and maintains flexible schedule as required by a protocol or site needsRequired Job Skills:Required: Clinical Research Coordinator experience (minimum 2 years, ideally more)Preferred: Certification such as an RN, LPN, MA, phlebotomy, or similar.EDC experienceEMR ExperienceVerbal and written communicationGoal-oriented; self-directiveOrganizational and interpersonal skillsAbility to be a team playerMentoring/training of new CRCsTalking on phone/in person; frequentlyNexGen Research, LLC is committed to equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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