Clinical Research Assistant

Job Summary:
Detailed understanding of each study protocol and backgroundknowledge of the study medication and therapeutic area under study;determine subject population availability and list and clarify concernswith the Principal Investigator (e.g. inclusion/exclusion criteria,concomitant medications, medical history, baseline imaging
requirements).

* Understand the requirements and objectives of eachclinical protocol; research questions regarding protocol or eligibility forphysicians or support staff; respond to requests from sponsors regardingpatient data; independent development and execution of all aspects ofprotocols; coordination of early and late phase trials in
investigator-initiated, NCI sponsored, and industry trials; complianceassurance with federal guidelines.

* Follow patient course of treatmentby ensuring all procedures are being conducted per protocol, collectingappropriate data from medical records; distribute and collect specifiedsurvey instruments; monitoring patients closely for any associatedadverse events.

* Maintain clinical research records; maintain files ofapproval letters and annual review reports; maintain records of closedprotocols for physician use/queries on patients; distribute protocols and
updates to appropriate personnel.

* Assist investigators withcorrespondence with both local and central Institutional Review Boards,including preparation of new and renewal applications, amendments,protocol deviations, adverse event reports, as requested.

* Manageresearch subject follow-up including visits or contacts based on studycalendar and protocol.

* Performs study related tasks, including patientinterviews, clinical data collection, specimen collection and shipping,certified testing, and other duties as assigned.

* Interacts withinvestigators and their staff to facilitate and monitor the conduct of multidepartmental clinical studies.

* Collaborates with principal investigatorsand other departmental staff in the delivery and improvement of servicesby identifying problems, analyzing work processes, recommendingimprovements, 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 variousdepartments including surgery, medical oncology, gynecologicaloncology, radiology, pathology as well as travel to various satellitelocations 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 ClinicalResearch Professional (CCRP) certification.
Work Days:
Monday - Friday varies
Message to Applicants:
G5: $19.50 - $30.48

Please note the salary information shown is a general guideline only. Salaries are based upon candidate skills, experience, and qualifications, as well as internal equity, market and business considerations.
Recruitment Office: MedBest Medical Management