Clinical Research Coordinator - Psychiatry

Responsibilities

• Implements, coordinates and performs daily clinical research activities in accordance with approved protocols (60%)
• Assists with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols
• Recruits, interviews and enrolls patients
• Obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements
• Educates patients and families of purpose, goals, and processes of clinical study
• Ensures initial and follow-up appointments are appropriately scheduled and fulfilled for participants to receive patient care services according to protocol
• Coordinates scheduling and follow-through of surgeries, medical procedures, & other diagnostic testing
• Collects and documents medical histories
• Participates in the collection, processing & evaluation of biological samples
• Administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires
• Coordinates and documents care of patients
• Assists with monitoring patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care
• Documents unfavorable responses and notifies research sponsors & applicable regulatory agencies
• Participates in evaluating patients for compliance related to protocol
• Assists with collecting, extracting, coding, and analyzing clinical research data; compiles and enters clinical research data into study database; generates reports and reviews to ensure validity of data; assists with development of clinical research study database; assists with writing sections of manuscripts, articles and other media for publication and presentation (15%)
• Participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements; assists with planning and development of clinical study processes (10%)
• Prepares and submits regulatory documents to applicable governing agency related to the conduct of human subject research; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA, federal, state and industry sponsor regulations; assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; participates in planning, organizing and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; completes case report forms (10%)
• Attends departmental meetings; attends national professional and scientific conferences to continue professional development; completes special projects as required (5%)
• Collecting and organizing data (20%)

Qualifications

• Bachelor’s Degree in Biological Sciences, Health Sciences or medical field, or equivalent combination of education experience required
• 0 years of relevant experience required
• 2-4 years of relevant experience preferred