Clinical Research Coordinator I

Responsibilities

• Responsible for the integrity and overall quality of assigned clinical research trials
• Organizes and leads assigned studies
• Communicates with the sponsor’s site monitors, Clinical Research Associates (CRAs), and local and/or central Institutional Review Boards (IRBs)
• Prepares, schedules, and leads and/or participates in study visits with monitors, sponsors, and auditors
• Fulfills GCP regulations, state and local laws, and study protocols
• Participates in the Informed Consent process, potentially including drafting, amending, and conducting Informed Consent visits with study subjects
• Reviews protocols to ensure they fit with the SDRI mission statement and can recruit the required subject population
• Create and maintain source documents
• Completes Case Report Forms (CRFs) for assigned studies and enters electronic data as required by the study
• Completes and submits Adverse Event (AE) forms per protocol and regulatory guidelines and Serious Adverse Events (SAE) forms to the sponsor and the IRB within 24 hours of SAE occurrence
• Supervisees recruitment process for assigned studies, screens potential subjects, and conducts subject visits
• Establishes and maintains relationships with study subjects and provides specific trial information to each subject/volunteer
• Completes regulatory documents for assigned studies, including submission for IRB initial approval and applicable renewals
• Attends Investigator Meetings as assigned
• Maintains drug and device accountability and dispensing logs for assigned studies
• Completes clinical duties such as completing comprehensive medical history for study subjects, measuring vital signs, phlebotomy, and blood sample processing
• Laboratory duties include centrifugation of blood samples, processing and packaging of body fluid samples, proper sample storage, and proper shipment of samples
• Aids in medical writing as appropriate and assigned, including protocols, scientific papers, and grant writing
• Performs other duties as assigned by superiors

Qualifications

• Basic knowledge of accepted clinical research practices, including universal precautions, human subjects research protocols, and HIPAA requirements
• Knowledge of drug development process, ICH guidelines, and FDA CFRs
• Ability to lead studies independently
• Ability to handle 3 or more studies simultaneously
• Ability to work independently and with careful attention to detail as well as in collaboration with other staff members
• Basic knowledge of office practices and office equipment
• Basic knowledge of computer systems for word processing, electronic mail, data entry, and electronic data transfer
• Basic typing skills
• Excellent multi-tasking, prioritization, communication, and organizational skills and ability to work under stress
• Ability to transfer and record data accurately, in the required format, and in a timely manner
• Proven ability to deal with problems with several variables and ability to prioritize tasks and activities in a manner consistent with direction from supervisor
• Proven ability to think and reason critically
• Experience working in a medical setting
• At least two years of experience working in clinical research
• High school diploma and Bachelor’s degree or equivalent experience
• Scientific or nursing education desirable
• Phlebotomy skills desired
• ACRP CCRC certification highly desirable
• Language Skills: Ability to read, write and speak English clearly, interpret documents, and communicate in scientific language
• Spanish proficiency and/or fluency desired
• Physical Demands: Regularly sits, talks, hears, and climbs stairs; frequently uses hands to finger, handle or feel equipment, paper, or files; stands, walks, and reaches with hands and arms; lifts and/or moves up to 10-20 pounds; occasionally lifts and/or moves up to 20-30 pounds; must be in sufficient overall health to report for work consistently and reliably and work through a standard day with appropriate breaks
• Work Environment: Office setting with clinical facilities and laboratory facilities; noise level in the work environment is usually moderate and illumination is primarily with fluorescent artificial lighting; exposure to biohazardous materials and communicable disease requiring the use of universal precautions at all times