Research Coordinator II - Pediatrics - Hematology & Oncology Clinical Research
Job Description
Summary
Job Duties
Supports daily operations for a research study or clinical trial
- Consults with the Principal Investigator (PI) and providers regarding research data.
- Assists the PI and/or providers with study patient enrollment.
- Interviews, screens, and recruits patients for therapeutic and non-therapeutic studies; performs the informed consent process for biology, procurement, and registry studies; and explains processes and procedures to educate participants about the research study.
- Collects patient information through direct interviews, questionnaires, and chart abstraction; processes documents and enters information into databases or case report forms (CRFs).
- Collaborates with study teams and physicians to determine patient eligibility for research protocols.
- May schedule research participants for tests and procedures (e.g., laboratory tests, X-rays, and other protocol-specific studies) and retrieves and submits results to appropriate parties.
- Works with multiple departments to coordinate diagnostic procedures.
- Assists with site selection and site initiation visits by coordinating schedules with external monitors and internal departments.
- Collects, evaluates, enters, and tracks research data.
- Collects research patient information (e.g., medical history, lab results) from the electronic medical record (EMR).
- Maintains accurate source documentation and CRFs in compliance with study protocols.
- Reviews research orders in Epic/Beacon with providers to ensure accuracy and completeness.
Submits data, study documents, and/or reports to regulatory agencies
- Submits accurate research data via CRFs to external entities in a timely manner.
- Provides prompt and appropriate responses to sponsor data requests or queries.
Assists with completion of protocol-specific documents
- Monitors protocol compliance and communicates deviations, errors, or incomplete documentation appropriately.
Establishes study files and prepares study-related documentation
- Creates and maintains research charts.
- Updates internal and external databases in accordance with departmental, sponsor, and study requirements.
Collects samples from participants
- Collects, processes, ships, and maintains documentation for blood and/or biological specimens according to study protocols and standard operating procedures (SOPs).
Performs other job-related duties as assigned
- May order supplies and equipment.
- May perform neurocognitive testing.
- Seeks guidance from the Clinical Research Manager for additional assignments.
% of Time Spent on Duties
- 30% – Informed consent and patient recruitment
- 20% – Biological sample management
- 20% – Data abstraction
- 15% – Data management and query resolution
- 10% – Research document completion (e.g., CRFs, study logs, internal reports)
- 5% – Research chart organization
- Performs other job duties as assigned.
Minimum Qualifications
- Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
- One year of relevant experience.
Preferred Qualifications
- Requires effective verbal and written communication skills.
- Requires proficiency with computers, internet and Microsoft Office applications.
- May require experience with computer spreadsheets and database management.
- May require the ability to understand and implement patient studies and protocols.