Obtains medical history and current medications, reviews protocol inclusion/exclusion criteria, and confirms eligibility of subject. Ensures that the informed consent process has occurred, is properly documented and filed as required.
Interviews prospective subjects for multiple clinical studies. Familiarizes potential subjects with the details of the study through phone contacts and personal interviews.
Schedules subject participation in research, coordinating availability of necessary space, and clinical support (including but not limited to physician, nurse practitioner, laboratory, radiology, pharmacy). Is familiar with all records required for each study, reviews records after each visit for completeness and accuracy
Abstracts and records all patient data essential to the study onto required Case Report Forms (CRFs) and into the Clinical Trials database (eDC), as needed, in an accurate and timely fashion. Maintains patient clinical research files.
Reports adverse events and serious events to appropriate parties; e.g. Principal Investigator, Study Sponsor, FDA, QA Department, Regulatory Affairs Coordinator, as required.
Serves as a contact person for ongoing clinical research studies. Schedules monitoring visits and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of study records.
Implements care and services that recognize age-specific needs and issues for customers served.
Participates in Internal / external audits.
Patient Care Responsibilities
Collaborates with hospital staff to ensure tests and procedures required by clinical protocols are performed and documented. These include, but are not limited to vital signs, phlebotomy, specimen processing, EKG's, drug administration, and protocol specific tests and procedures.
Will be called upon to perform the following specific tests and procedures: a) electrocardiogram, b) blood pressure, pulse, height, weight, and temperature measurements, c) phlebotomy (direct venipuncture) d) specimen processing and shipping
Requirements:
Bachelor's degree, or graduate from an LVN / RN school of nursing, or equivalent medically-related education at an Associate's degree level, and at least 2 years of clinical research experience. Phlebotomy and Lab processing experience preferred, ACRP or SoCRA certification strongly preferred. Knowledge of clinical research procedures, GCP, HIPAA, and strong interpersonal and organizational skills are also necessary.
Required experience:
Clinical Research Coordinator: 2 years (3 years with AA degree)
Rating scale experience a plus
Regulatory experience is mandatory
Inpatient, psychiatric and/or oncology experience a plus
Required Competencies/Knowledge, Skills and abilities:
Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task.
Good command of the English language, both written and verbal.
Excellent attention to detail and ability to interpret and master complex protocol information.
Desired Qualifications:
Experience with Memory loss and CNS studies
Physical Demands: (e. g., lifting, standing, walking)
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
EEO / AA / F / M / Veteran / Disabled
Some travel required
401k matching
M-F work schedule
Full Time position
Benefits packages