Sr Coord, Clinical Studies-Infectious Disease & Infection Ctrl-Rsch

Summary

Provides leadership support in the area of research in Infectious Diseases in cancer patients: Provides independent and advanced patient care services and operational management for clinical trials. Leads the regulatory aspect of the clinical trials and protocols. Prepares for internal and external auditing.

 Scope: Impacts clinical research; protocols and the patients enrolled in designated protocols. Ensures strict adherence to the policies, reporting mechanisms, and procedures of the institution.

Key Functions

1. Assists the faculty investigator in the overall conduct of the clinical trials assigned. Contributes in the department of ID/IC/EH protocol review and submission process include amendments, and continuing reviews. Will attend research/protocols meetings.

2. Responsible for the overall effective operations of designated protocols to include development, design, maintenance, and resolution of any logistical issues in the protocol in collaboration with the PI and/or study sponsor.

3. Works with the Manager, Clinical Protocol Administration regarding adherence to study budget including but not limited to the review of coverage analysis, patient enrollment, tracking of schedule of events by patient and communicating any events outside the schedule of events that need to be invoiced separately with study sponsor.

4. Provide protocol training for all staff and is responsible for following all policies and procedures related to the conducting clinical trials to ensure protocol compliance, including maintenance of regulatory and patient binders for each study.

5. Responsible for reporting to the investigator and supervisor any Adverse Events (AE), Serious Adverse Events (SAE, deviations, and/or violations that occur in the life of the study.

6. Coordinates FDA visits, prepares regulatory documents for onsite visits and supervises external clinical study monitors and/or auditors.

7. Performs internal audits to monitor compliance and accuracy of data.

8. Manages protocols at appropriate intervals and participates in monitoring and audit activities. Ensures that the conduction of assigned studies is in accordance with Good Clinical Practice, Federal regulations and institutional policies.  Develops and maintains systems for the coding, editing, and computer entry of data for assigned research studies focusing on continuous patient follow-up. Maintains research databases for the department and institutional databases for various internal research studies and works closely with the sponsor representative on sponsor studies to meet data requirements and deadlines.

9. Spends 40% or more time in direct patient contact.  Obtains consent for minimal risk studies. Scheduling, follows-up either in person or via telephone.  If needed, coordinates labs, out-patient orders, patient diaries, drug accountability as outlined in the protocol.

10. Assists the faculty investigator(s) in data collection, submission/entry of data, study file preparation, and attends data review meetings as required. Prepares specific protocol reports and analysis and assist in manuscript preparation and grant submissions, as appropriate.

11. Participates and ensures prospective/retrospective data collection is entered in a timely manner into the departmental database and/or study CRF/eCRF provided by the sponsor. Oversees the timely response to queries from sponsor on data reported via CRF/eCRF.

12. Attends departmental meetings as required. Attends weekly research team meetings. Participates in the evaluation process.

13. Other duties as required.