Clinical Research Assistant

Job Summary :

Detailed understanding of each study protocol and background knowledge of the study medication and therapeutic area under study;

determine subject population availability and list and clarify concerns with the Principal Investigator (. inclusion / exclusion criteria, concomitant medications, medical history, baseline imaging

requirements).

• Understand the requirements and objectives of each clinical protocol; research questions regarding protocol or eligibility for physicians or support staff;
• respond to requests from sponsors regarding patient data; independent development and execution of all aspects of protocols;

coordination of early and late phase trials in

investigator-initiated, NCI sponsored, and industry trials; compliance assurance with federal guidelines.

Follow patient course of treatment by ensuring all procedures are being conducted per protocol, collecting appropriate data from medical records;

distribute and collect specified survey instruments; monitoring patients closely for any associated adverse events.

Maintain clinical research records; maintain files of approval letters and annual review reports; maintain records of closed protocols for physician use / queries on patients; distribute protocols and

updates to appropriate personnel.

• Assist investigators with correspondence with both local and central Institutional Review Boards, including preparation of new and renewal applications, amendments, protocol deviations, adverse event reports, as requested.
• Manage research subject follow-up including visits or contacts based on study calendar and protocol.
• Performs study related tasks, including patient interviews, clinical data collection, specimen collection and shipping, certified testing, and other duties as assigned.
• Interacts with investigators and their staff to facilitate and monitor the conduct of multi departmental clinical studies.
• Collaborates with principal investigators and other departmental staff in the delivery and improvement of services by identifying problems, analyzing work processes, recommending improvements, and participating in the implementation of changes in workflow.
• Assists in preparation for any site visits such as auditing, monitoring, and site initiation or closeout visits.
• Interaction with various departments including surgery, medical oncology, gynecological oncology, radiology, pathology as well as travel to various satellite locations within these departments.
• Participate in billing support, budget negotiations and regulatory compliance per federal guidelines quality assurance, internal audits, and other duties as assigned.

Minimum Qualifications :

Bachelor's degree and up to 2 years related experience. Knowledge of medical terminology, excellent written and oral communication and organizational skills, and basic computer skills.

Will consider equivalent combination of education and experience.

Preferred Qualifications :

Prior experience with clinical research protocols. Certified Clinical Research Professional (CCRP) certification.

Work Days :

Monday - Friday varies