Coordinator

Position Summary:

Serves as the project coordinator on multiple clinical research studies for various sponsors including government agencies, cooperative groups, pharmaceutical companies, biotechnology companies, and/or medical device companies. May also serve as the coordinator for internal investigator initiated clinical research.

Must follow the study protocol as designed and written by the study sponsor adhering to Good Clinical Practice as defined by the U.S. Food and Drug Administration, as well as other appropriate regulatory agencies. Works with study investigators, Research nurses, supervisor, and other organization team members to address study-related issues. Back up other coordinators as needed.

Coordinates collection of data per protocol, operations manuals, CRF guidelines and enters data into eCRF systems.

Identifies strategies to improve patient enrollment in research protocols.

Participates in PSSVs, SIVs, and Investigators' Meetings for assigned trials and follows all schedules agreed with Sponsor.

Provides or enters study data into Clinical Trials Management System (CTMS) for all assigned studies.

Schedules and manages sponsor initiated monitor visits, quality assurance audits, other periodic reviews and data queries, providing information requested.

Screens patient records, databases, physician referrals, etc., to identify prospective patients for studies.

Prepares study-related documents such as protocol specific sources, protocol review form, nursing information sheets, clinical trial information sheets, etc.

Manages all Study supplies.

Directs the conduct of multiple clinical research studies performing procedures as outlined in the research protocol in compliance with FDA regulations and GCP.

Reports adverse events and serious adverse events to the Sponsor and Regulatory Coordinator at the direction of the protocol, Sponsor, Research Nurse and PI.

Position Qualification:

2 years college, technical school, or equivalent experience

1 year related work experience