Clin Research Data Coord I

Essential Functions:

• Responsible for working collaboratively with clinical research coordinators, regulatory coordinators, physicians, nurse clinicians, pharmacy, and laboratory personnel to ensure tests/procedures/specimen collections, etc. are obtained per protocol.
• Assist in the identification, collection and reporting of adverse events and serious adverse events in accordance with ICH, CFR, GCP and protocol specific guidelines.
• Prepare and provide patient status reports to leadership as requested
• Serve as point of contact for respective sponsor monitoring visits
• Ensure accurate and timely retrieval and submission of protocol driven data points from internal and external sources including but not limited to data forms, study related materials (slides, pathology, operative reports, and radiology reports) to the relevant cooperative or industry-based groups for patients placed on clinical trials.
• Participate in audits conducted by sponsors and other regulating authorities.
• Identify, research, resolve and report data discrepancies
• Prepares new study patient charts
• Maintains a registry of study patients at the relevant time points
• Assists in the internal data quality and control process.
• Conduct survival follow up visits as applicable.
• Understanding of project management concepts in order to aid delivery across program
• Ability to influence and communicate across functions and external stakeholders
• Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards.
• Maintains compliance with all Orlando Health policies and procedures.

Other Related Functions:

• Attends appropriate departmental, corporate and continuing education meetings as required.
• Assumes the responsibility for professional growth and development.
• Transmits data to sponsoring and regulatory agencies.

Education/Training:

• Associates degree OR;
• Bachelor’s degree.
• If no degree, experience may be substituted at a 2 for one ratio.
• Experience with Microsoft Windows operating system and Microsoft Office to include Word, Excel, PowerPoint, and Access.
• Previous experience working in a healthcare related or clinical research setting preferred.
• Previous oncology experience preferred

Licensure/Certification:

• Orlando Health phlebotomy course within 30 days of hire is required within certain areas.

Experience:

• Two (2) year’s experience working with data or medical information to include quantitative duties such as data collection, management and verification. Post-secondary education may offset experience on a 1 to 1 basis.