Required Education / Experience:
· High school diploma required. Allied health degree or degree/certification in health/biological science or Bachelor’s degree in a health/biological science field (preferred)
· Experience in data abstraction from clinical records
· Training or experience or training in the conduct of clinical research (preferred)
· Training or experience in the oncology field (preferred)
· Maintain professional certifications, licensure and credentialing as required
· Successful completion of CITI training (GCP, Protecting Human Research Participants) within one month of employment; ongoing maintenance of training is required
· Successful completion of dangerous goods shipping training within one month of employment
· Successful completion of Clinical Research Coordinator Certification (Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Professional (SoCRA)) recommended within two years of eligibility
Job Summary:
Reviews, abstracts, and validates clinical information of subjects enrolled in clinical research trials. Primary responsibility for timely and accurate entry of research subject data to electronic data capture programs maintained by protocol sponsors. Assist with receipt and inventory management of research specimen kits and study drugs. Assist with collection of research specimens and responsible for shipping to protocol sponsors.
Major Responsibilities / Duties / Critical Tasks:
• Ensures that clinical participant data is abstracted and reported clearly, accurately, and securely to the protocol sponsor and/or their designee using electronic and paper systems
• Responsible for efficient and timely query resolution of entered data
• Entry of clinical data to the clinical trials management system (CTMS)
• Proficiently manages data management of multiple clinical studies concurrently
• Review medical records for evaluation and collection of clinical information during screening for and participation in clinical research studies
• Assist with collection, maintenance, and shipping of biological specimens collected from research subjects
• Assist with managing inventory and supplies needed to fulfill protocol requirements, including investigational agents and protocol specific central laboratory supplies
• Attend study-related meetings (virtual, on-site, and/or off-site) as appropriate
• Primary responsibility for maintenance of shadow charts for source documentation for all eCRF entries, including clinic chart visit notes, lab data, and procedure reports.
• Assist regulatory to ensure that all study documentation (shadow charts, patient and drug logs, etc.) is appropriately filed at study close out
• Other duties as assigned
Knowledge, Skills, Abilities and Competencies:
· Analytical and critical thinking skills with high attention to detail
· Excellent organizational and verbal and written communication skills
· Ability to multi-task and manage multiple assignments concurrently with independent dynamic assessment of priorities to meet goals and deadlines
· Ability to work effectively in a fast paced, team-based environment and establish positive working relationships with patients, research staff colleagues, and clinical staff
· Proficiency with computer applications, including but not limited to the Microsoft Office applications
· Experience in data extraction from medical records
· Proficiency with medical terminology