Clinical Trial Professional

Target Pay Rate: 60-80.84/hr **salary will be commensurate with experience

Position Summary

The Clinical Trial Professional/Leader provides clinical trial oversight to the assigned clinical trial ensuring deliverables are met in terms of quality, compliance and timing. Strong external vendor and CRO management skills are critical for this role and this role is accountable for assigned studies. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

This position reports to the Executive Director, Development Operations and can be based remotely from a location within the US.
(2) part-time positions, 20 hours per week each, to support the clinical operations group.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

• Day to day management of assigned clinical trial to ensure deliverables are met in all phases of the assigned trial(s).
• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives.
• Communication to internal team members on deliverables.
• Coordinate clinical study timelines with Project management to meet critical milestones and escalate issues that may jeopardize timelines and deliverables.
• Proactively assess potential risks to the study and propose mitigation plans.
• Ensure set-up and implementation of effective investigator and site monitor training.
• Provide oversight and direction to study team members, including vendors, for study deliverables.
• Manage trial feasibility and site selection process.
• Work closely with study Clinical Operations Leads to execute clinical studies.
• Participate in the review, development and/or writing of clinical trial documents and manuals, such as protocol, informed consent form and site materials including training, manuals and support documentation.
• Monitoring of clinical data to ensure timely entry and readiness for data review meetings.
• Periodic review of clinical data
• Review of clinical monitoring reports to ensure timely completion and identification of issues.
• Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables.
• Maintain trial metrics.
• Ensure trial is conducted in accordance to and ICH/GCP standards including multiple regions in global trials
• Support testing clinical trial systems/databases (i.e. UAT)
• Develop and maintain strong, collaborative relationships with key stakeholders.

Qualifications

• At least 5-10+ years of trial coordination experience in a clinical research environment required.
• Oncology or Neurology experience required. Ability to manage multiple projects concurrently.
• Experience in clinical pharmacology healthy volunteer studies and/or with Trial Master File implementation is highly desirable.
• Relevant experience in global setting managing CROs and multiple study vendors
• Solid understanding of drug development
• Good project management skills
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies

Education

• Bachelor’s degree in a clinical or science-based subject

**CO/NY candidates may not be considered