SKILLS, KNOWLEDGE, EDUCATION AND EXPERIENCE:

• Bachelor’s degree preferred or equivalent combination of education and recent experience.
• Minimum 2 years of experience in clinical research; experience at the site level or within the industry preferred.
• Recent experience in clinical patient care setting with demonstrated proficiency in oncology specific medical terminology and confidence in EPIC navigation.
• Medidata Rave experience is preferred.
• Certification with Association of Clinical Research Professionals (ACRP) or CRPC (Clinical Research Professional Certification) with Society of Clinical Research Association (SOCRA) preferred

GENERAL SUMMARY AND PURPOSE:

Saint Alphonsus is looking for a Data Coordinator in support of Oncology Clinical Research. This position is accountable for meeting all study-specific data collection goals and data entry timelines. Data will be collected from a variety of sources and recorded into trial specific databases, while simultaneously addressing and amending ongoing data queries from previously reported data. Attention to detail with proven organizational skills across multiple projects is of critical importance to ensure accuracy and integrity of reported data. The position assumes responsibility for coordinating and facilitating all study specific audits and serves as the primary point of contact for data management needs, process and procedure. Effective communication across entirety of research team and external collaborators is necessary to maintain successful collaboration amongst all individuals. Supports clinical research coordinators with regulatory tasks as needed and in accordance with licensure and competency.

ESSENTIAL FUNCTIONS:

• Knows, Understands, Incorporates, and Demonstrates the Organization’s Mission, Vision, and Values in behaviors, practices, and decisions.
• Facilitates high quality customer service by communicating clearly and efficiently with adherence to identified timelines.
• Review and support implementation of the Trinity Health Integrity & Compliance policies and procedures pertaining to research (“Trinity Research Compliance Policies”).
• Continually evaluate and monitor compliance with such policies and procedures on an ongoing basis.
• Ensures compliance with institutional, federal and state regulation, guidance and policy.
• Evaluates and analyzes medical records and related source document for case report form completion.
• Provides efficient and complete data collection, review and reporting.
• Assures availability of source documentation for all reported data and maintains organization of sources for future audits.
• Manages study specific databases to ensure timely completion of active and long-term follow-up research participants with protocol specified timelines.
• Utilizes multiple data captures systems and resources, including various health care delivery components, to identify, track and analyze participant data prior to submission where data may include paper or electronic data and biological specimens.
• Supports, as needed, the processing, tracking and shipment of biological systems, including blood and tissue.
• Collaborates with the oncology clinical research team to prepare for internal and external audits and maintains primary accountability for quality and completeness of all study data.
• Consistently protects patient and data confidentiality by ensuring the security of collected research data and related protected health information (PHI) and maintains compliance with applicable federal regulations and sponsor protocols.
• Ability to interpret and master complex research protocol information.
• Evaluates study data to ensure protocol compliance.
• Contributes to development of process and procedure for collection of data that may not be collected as part of routine care but is required by a study protocol.
• Confidence in communication with providers and/or supporting service lines to achieve clarification or confirmation of collected data prior to reporting.