This position provides support to the Investigators and research team members in reviewing medical records for cancer research studies. This position may also conduct data entry, long-term follow-up, query resolution, data reconciliation, database management and documentation, and reporting and regulatory oversight, e.g., IRB reporting, regulatory filing.
- Conduct medical record review and data linkage
- Conduct clinical data review and long term follow-up activities according to the protocol, SOP, and Data Management Plans (may involve obtaining medical records from outside institutions)
- Assist with data reconciliation, e.g. medical records, core labs, central labs, images, pathology, and inventory administration
- Support CRF or database completion and query resolutions in a timely fashion; support maintenance, distribution and tracking of study participants data collection activities
- Review, report or complete any outstanding forms or reports for Sponsor or other stakeholder
- Support regulatory maintenance and documentation of clinical research data activities, e.g. site communications, correspondence, key personnel
- Conduct study communications with the IRB of record and maintains study records to assure good standing with other regulatory bodies and Sponsor
- Support clinical research activities as required
- A minimum of 1 year related healthcare or clinical research work experience required and a high school diploma or equivalent is required
- Strong computer, written, organizational, communication, self-auditing and interpersonal skills are required especially surrounding the sensitive end-of-life situations encountered by subjects and their families
- Must be able to perform from both oral and written instructions, manage multiple tasks, attention to detail and adapt to changing work-loads, priorities, data entry systems and patient tracking requirements
- Person must work well independently and in a team environment
- Analytical skills is preferred
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.