Clinical Data Coordinator, Oncology Job ID 2023-127929 Department Clinical Trial – JS Hope Tower Site Jersey Shore Univ Med Cntr Job Location US-NJ-Neptune Position Type Full Time with Benefits Standard Hours Per Week 40 Shift Day Shift Hours 8:30 a.m. – 5:00 p.m. Weekend Work No Weekends Required On Call Work No On-Call Required Holiday Work No Holidays Required Overview How have YOU impacted someone’s life today? At Hackensack Meridian Health our teams are focused on changing the lives of our patients by providing the highest level of care each and every day. From our hospitals, rehab centers and occupational health teams to our long-term care centers and at-home care capabilities, our complete spectrum of services will allow you to apply your skills in multiple settings while building your career, all within New Jersey’s premier healthcare system. The Clinical Data Coordinator, Oncology maintains essential study documents for clinical research studies and enters data onto Case Report Forms and ensures study compliance. Responsibilities A day in the life of a Clinical Data Coordinator, Oncology at Hackensack Meridian Health includes: Prepares reports and assists with statistical analysis. Assists research nurses in the preparation of all audits performed by various governing agencies, study monitors, and internal affairs. Assures timely submissions of research data, laboratory specimens, and query correspondences to all research affiliates and statistical centers. Obtains and maintains valid Dangerous Goods Shipping Certification. Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Contract Research Organizations, and employees of Hackensack Meridian Health. Obtains patient consent for minimal risk studies. Organizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits. Verifies that all patients have provided informed consent prior to entering study specific data. Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs. Records accurate data by completing paper or electronic CRFs. Resolves data queries accurately and within study specific timeframes. Maintain adequate inventory of research supplies necessary for research activities. Ensures supplies and kits are current and safely dispose of expired/closed supplies. Centrifuges human specimens per study specific laboratory manual guidelines. Processes and ships human specimens and biologic agents per protocol guidelines and Federal Regulations. Maintains timely patient follow-up by accurately reviewing the study specific follow-up schedule in protocol and completes follow-up CRFs. Reports the, tracks, and files off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record. Utilizes the SAE reporting log to track the receipt, submission and acknowledgement of off-site SAEs per protocol. Prepare reports, including but not limited to enrollment logs which assist with institutional statistical analysis. Provides technical assistance and instruction to students, employees, and medical residents. Runs reports and reviews study information in the clinical trial management system. Identifies the needs of the patient population served and modifies and delivers care that is specific to those needs (i.e., age, culture, language, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.). Other duties and/or projects as assigned. Adheres to HMH Organizational competencies and standards of behavior. Qualifications Education, Knowledge, Skills and Abilities Required: Bachelor’s degree in Science (Chemistry, Biology, Nursing) or equivalent experience. Prior experience in research that includes data abstracting, case report form completion and research regulatory reporting. Excellent written and verbal communication skills. Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms. Education, Knowledge, Skills and Abilities Preferred: Minimum of 3 or more years of experience in research that includes data abstracting, case report form completion and research regulatory reporting. If you feel that the above description speaks directly to your strengths and capabilities, then please apply today! Need help finding the right job? We can recommend jobs specifically for you! Click here to get started. Meridian Health is committed to the principles of equal employment opportunity and affirmative action and will not discriminate in the recruitment or employment practices on the basis of race, color, creed, national origin, ancestry, marital status, gender, age, religion, sexual orientation, gender identity/expression, disability, veteran status and any other category protected by federal or state law.
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