Start- up CRA, Oncology- MIDWEST

We are Translational Drug Development - TD2:  the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move your medicines from preclinical development into clinical trials. Adaptive and forward-thinking, we guide your therapy through the most critical development milestones from the lab to planning your regulatory and clinical strategy. Our ultimate goal? To help patients.

Preferred Locations:

• Mid Western USA

Position Summary:

This position is responsible for conducting trial study start-up activities as it relates to monitoring, specifically the conducting Site Qualification Visits and Site Initiation Visits.  Additionally, if required, this position is responsible for Trial Master File reconciliation, co-monitoring, conducting centralized monitoring visits, conducting blinded monitoring visits and conducting Close-out Visits to clinical trial research sites during the course of the trial to ensure research trials are completed in compliance with the protocol, GCP, FDA regulations, ICH guidelines, and overall clinical objectives.

Essential Functions:

• Presenting / Hosting Site Qualification Visits and Site Initiation Visits both remote and onsite.
• Co-monitor all aspects of assigned Phase I-III oncology clinical trials to ensure the protection and welfare of subjects, compliance with the protocol, GCP/ICH guidelines, FDA regulations, and overall clinical objectives.
• Organize and perform site qualification, site initiation, interim monitoring, and site close-out visits according to TD2 policies and procedures.
• Write Monitoring Visit Reports after each visit within the allotted timeframe along with preparing Confirmation and Follow-up Letters.

Job Requirements:

• Minimum of three years of work as a CRA in a CRO or Sponsor
• Minimum of two years of experience monitoring Phase I oncology clinical trials
• Minimum of two years of experience in the therapeutic field of oncology
• Strong knowledge of GCP, ICH, and FDA regulatory requirements

Required Specialized/Technical Skills:

• Excellent presentation skills
• Strong organizational skills
• Strong communication skills
• Strong computer skills in Microsoft Office tools, Site EMR, EDC, and CTMS systems
• Field-based with ability for 75% overnight travel

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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