"Clinical Research Assistant B"

Job Description Summary

Assist with study coordination and recruitment for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects within the Renal, Electrolyte, and Hypertension Division. Works directly with study physicians, research nurses, study coordinators, and other research staff. Performs recruiting, preparing charts, creating source documents, ordering of supplies and equipment, study visits, consenting of participants, processing and shipping of labs, entering data into databases, picking up and delivering supplies and specimens, and escorting participants to other testing/procedure areas. Maintain and file study records, logs, databases, and spreadsheets. Knowledge of medical terminology and ability to read lab reports needed. Familiarity working with Penn chart is preferred. Willing to learn medical procedures, ie, phlebotomy, ECG, etc. Must be willing to work a flexible schedule that would include occasional early mornings, late evenings and weekends.

Job Description

Job Responsibilities

We are looking for a highly motivated, dedicated and enthusiastic individual who will provide study assistance/coordination for patient-oriented clinical and translational research projects within the Renal Division. The primary duties will include, but are not limited to:

• Assist with Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments, and adverse event reporting.
• Assist, process, file, and organize study and regulatory documentation.
• Assist in the coordination, creation, organization, and maintenance of all documentation, logs, spreadsheets, and databases required by sponsor or clinical research organizations (CROs) - source documentation, case report forms, study and regulatory binders, and patient binders.
• Assist in resolving regulatory-related queries with IRB, study sponsors and CROs.
• Work with research sponsors, CROs, or regulatory agencies on study initiation, monitoring, closeout visits, and any audits.
• Research data entry.
• Assist with performing study visits, consenting of participants,
• Picking up and delivering supplies and specimens, and escorting participants to other testing/procedure areas
• Recruit, screen, and enroll patients as specified per protocol.
• Schedule patient visits and necessary testing.
• Process and ship blood, urine, and serum specimens.
• Obtain records and any other material required to complete case report forms and comply with protocols
• Other duties and responsibilities as assigned

Qualifications

• High School Grad/GE Degree and 3 to 5 years of experience or equivalent combination of education and experience is required.
• Previous experience in a healthcare setting is preferred.
• Effective problem solving abilities.
• Effective communication and writing skills.
• Ability to multi-task.
• Demonstrated ability to work as part of a team as well as independently.
• Knowledge of IRB and human research protection regulations. Knowledge of medical terminology is required.
• Willing to learn procedures such as phlebotomy, EKG's, PWV's, etc.