Clinical Research Coordinator II - Oncology
- Requisition ID
- 01 - Days
- HHRI Oncolgy Clincl Trial
- Shea Medical Center
- Position Type
- Regular Full-Time
- Physical Work Location and New Employee Orientation Location : Address
- 10510 N. 92nd St
- Work Hours
HonorHealth is a non-profit, local healthcare organization known for community service and outstanding medical quality. HonorHealth encompasses five acute care hospitals with approximately 11,500 employees and 4,500 volunteers, over 70 primary and specialty care practices, clinical research, medical education, an inpatient rehabilitation hospital, an Accountable Care Organization, two foundations, and extensive community services.
HonorHealth is a leader in medical innovation, talent and technology with a genuine commitment to your growth. The health system's vibrant careers take place in an environment filled with opportunity and respect because we see the HONOR in you.
Bachelor's Degree in Health Science or 4 years of health science-related experience Required
2 years of progressively responsible clinical/clinical research or data management experience Required
The Research Data Coordinator II is the primary contact with the study sponsor and is responsible for the day-to-day management of project activities and resources and overall clinical data and protocol management for the conduct of therapeutic clinical trials at HonorHealth.
- Collects, verifies, organizes, completes and records clinical information and data in case report forms. Performs the following data related activities: CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation, resolve queries and safety coding. Assists with subject follow-up for clinical protocols and documents/report clinical study progress to assigned study team. Obtains all reports and submits data forms and pathology and radiology materials according to protocol requirements. Conducts protocol administration quality control monitoring, enforcement and database maintenance.
- Provides data management project leadership to support multi-disciplinary clinical trials, including patient screening for study eligibility, obtaining Informed consent and subject registration. Handles and labels samples and ships samples according to protocol requirements.
- Track study/clinical trials progress and issues periodic status reports. Communicates the achievement of key milestones such as draft or final database to the project team.
- Prepares annual reports and statistical information on all clinical research as required by System, IRB or investigators. Collaborates with Regulatory/IRB Coordinator as necessary.
- Acts as liaison in support of pharmaceutical and investigator initiated clinical protocols. May participate in site initiation, interim monitoring, and study close out visits with sponsor and FDA initiated audits as needed. Handles and labels samples and ships samples according to protocol requirements. Facilitates ongoing set up and closing of clinical protocols. Represents data management at business development related meetings. May assist in the creation of business development proposals by supplying data management related information and costs.
- Provides assistance as needed to peers to ensure that study deadlines are met. Identifies data management project issues and alerts senior department management with a view to recommendations. Maintains communication with supervisor regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices. Participates in mentoring and training of staff on data management procedures, and systems, including the mentoring of all direct reports. Performs other related duties as assigned.
It is the policy of HonorHealth to provide equal opportunity in employment. Selection and employment of applicants will be made on the basis of their qualifications without regard to race, color, religion, creed, national origin, age, disability, sexual orientation, marital status, veteran status or any other legally protected status.
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