Clinical Trials Coordinator Ii

Description:

The CTC II develops, coordinates and implements the management of the clinical endpoint adjudication process for Clinical Trials research conducted by Principal Investigator(s). The CTC II also performs a variety of duties involved in the organization, oversight, documentation and compilation of clinical research data. The CTC II is also responsible for the skills and responsibilities at the CTC I level.

Responsibilities

• Review CRF to assure compatibility with CEC trial responsibilities
• Depending on trial assignment, may coordinate the work of Clinical Data Assistants working on CEC aspects of the trial
• Use MS Access or other software for purposes of status reporting or communicating trial issues with project team
• Use Clinical Data Management software for tracking, running reports, or viewing CEC related data
• Serve as a mentor to CTC I by welcoming questions, sharing work, delegating progressive responsibility, reviewing their work and providing constructive coaching and feedback
• Make presentations to project teams and at investigator meetings
• Prepare CEC trial start-up materials
• Test trigger programming by manually reviewing appropriate percentage of first triggered cases
• Identify clinical data criterion algorithm used to trigger suspected events
• Define data integrity checks for event classification form
• In collaboration with PL & CEC faculty and trial protocol identify events to be reviewed
• In collaboration with PL & CEC faculty identify specific adjudication criterion for event classification
• Triggers to identify suspected clinical events
• Identify CRF variables/Data critical to the CEC process
• Process document (EndPoint definition, roles & responsibilities, source docs)
• Identify and communicate source documents and CRF data necessary for CEC
• Inservice fellows
• Perform review of adjudication to assure consistent application of endpoint definitions
• Work Instructions
• Train CDA’s, Trial team basic clinical training on CRF
• Presentation at investigators meeting
• Design EndPoint Classification forms
• Choose and implement tracking system and process
• Independently and consistently manage all aspects of CEC operations on multiple small Clinical Trials, or a large clinical trial including trials where the DCRI is collaborating with other organizations performing parts of the trial CEC process
• Participate in close-out committee decision making regarding (CEC timelines) to trial completion, resolution of unresolved events
• Other duties as assigned

Skills:

Clinical research, adjudication, CRF, CRF Review, CRA

Top Skills Details:

Clinical research,adjudication,CRF

Additional Skills & Qualifications:

1-2 years safety experience, RN, CRC, CRA or CTA exp

Completion of RN/PA/Pharmacist training and 2 years healthcare experience; or allied health degree and 5 years healthcare experience; or advanced degree in public health/related field and 1 year Clinical Trials research experience; or BA/BS and 3 years Clinical Trials research experience.

Experience Level:

Intermediate Level

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