CLINICAL RESEARCH COORD B/C

Location
Philadelphia, Philadelphia County
Posted
Mar 25, 2016

Duties: Coordinator B: With minimal supervision, coordinate Phase I-IV clinical trials. Recruit, consent and screen patients according to protocol. Schedule patient visits
and any necessary testing, Monitor patients per protocol requirements and ensure adherence to protocol requirements, Organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. Collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples. Participate in patient visits including scheduled study assessments such adverse events, concomitant medication reconciliation, questionnaires, visit calendars, and others as specified by research protocol. Work closely with Principal Investigator by facilitating review of labs in real-time and reviewing protocol to assess need for dosing schedule modifications. Participate in initiation, monitoring, audit and close-out visits, Participate in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings, Assist in the development/maintenance of study specific case report forms and source document tools, show vigilance in patient safety, protocol compliance and data quality. Assist in the monitoring of external sites and assist in the management of multisite trials. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
Coordinator C: Independently manage Phase I-V complex clinical trials, mentor coordinators and research assistants, consent and screen patients according to protocol. Schedule patient visits and any necessary testing, Monitor patients per protocol requirements and ensure adherence to protocol requirements, Organize and maintain all documentation required by the sponsor or CRO - includes source documentation, case report forms, and research charts. Collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples. Participate in patient visits including scheduled study assessments such adverse events, concomitant medication reconciliation, questionnaires, visit calendars, and others as specified by research protocol. Work closely with Principal Investigator by facilitating review of labs in real-time and reviewing protocol to assess need for dosing schedule modifications. Participate in initiation, monitoring, audit and close-out visits, Participate in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings, Assist in the development/maintenance of study specific case report forms and source document tools. As needed, monitor external research sites and manage various aspects of multisite trials. Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.

Position is contingent on continued funding.

Qualifications: Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.

Coordinator B: Bachelor's degree required and 2-4 years of related experience (or equivalent combination of education and experience.
Coordinator C: Bachelor's degree required and 4-6 years of related experience (or equivalent combination of education and experience.

Reference Number: 40-22414

Salary Grade: 026/ 027

Employment Type: Exempt

Org: CC-Cancer Center

Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

Job Family: I-Technical/Professional Research