Position Summary:
Under minimal guidance, this position is responsible for oversight of a portfolio of research projects. This position will lead the development and implementation of clinical research projects by collaborating with Principal Investigator and/or designees to ensure targets are met on time. Develop and implement enrollment strategies and study documents including protocol, and study manuals. Provide analytical, data management, and methodological support in the development of clinical research protocols and data management tools. Assist with the development and implementation of best practice guidelines for conducting various clinical research protocols. May train lab staff members and assist in writing articles and papers for submission.

Key Responsibilities:

• In conjunction with the PIs and/or designees designs, develops, and implement clinical research projects such as enrollment strategies, study materials, and study documents.
• Responsible for daily operations of the study. Develops and implements processes and procedures to meet study goals and protocol requirements. Participate in training and prepare study related training materials. Plans and prioritizes the work of administrative and support personnel on all clinical study activities.
• Consents and enrolls patients for research studies by providing detailed information on the Clinical Study to patients and families. Communicates all policies and procedures and responds to all inquiries. Evaluate the suitability of prospective study candidates and make selections based on clinical knowledge of each study. Provide input for updates of SOPs and drafting of new quality documentation.
• Assist with developing and implementing best practice guidelines for conducting various clinical research protocols. Presents and prepares training materials as part of the sponsored educational efforts.
• Provides analytical, data management, and methodological support to PIs in the development of clinical research protocols and data management tools. Manages data for single and/or multi-institutional investigations.
• Develops study specific data management and quality assurance procedures and monitors their implementation at site visits and/or periodic review of study data management reports.
• Works with PIs and lab members to plan analyses, clean and verify data and facilitate preparation of datasets for analyses.
• May assist in writing grants. Prepare new applications for research funding and implementing and managing ancillary study grants.

Minimum Qualifications
Education:

• A Bachelor’s Degree is required, Master’s Degree preferred.

Experience:

• Bachelor’s Degree with 4 years of relevant work experience; OR Master’s Degree and 2 years of relevant work experience is required.