Sr Clinical Data Coordinator, Cancer Center Clin Research
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POST DATE 9/18/2016
END DATE 2/28/2017
Hackensack University Medical Center
JOB DESCRIPTIONThe Sr Clinical Data Coordinator is responsible for the oversight of the data management process for their respective division(s). This includes, but is not limited to, data collection, subject registration, and protocol management. The Sr Clinical Data Coordinator will work closely with the Research Nurse Coordinator and Regulatory Specialist under the general supervision of the Principal Investigator. 1. Prepares reports and assists with statistical analysis. 2. Assures timely submissions of research data, laboratory specimens, and query correspondences to all research affiliates and statistical centers. 3. 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 University Medical Center. 4.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. 5. Obtains consent for minimal risk studies. 6. Verifies that all patients have provided informed consent prior to entering study specific data. 7. Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs. 8. Records accurate data by completing paper or electronic CRFs. 9. Resolves data queries accurately and within study specific timeframes. 10. Maintain adequate inventory of research supplies necessary for research activities. Ensures supplies and kits are current and safely disposes of expired/closed supplies. 11. Centrifuges human specimens per study specific laboratory manual guidelines. 12. Processes and ships human specimens and biologic agents per protocol guidelines and Federal Regulations. 13. Maintains timely patient follow-up by accurately reviewing the study specific follow-up schedule in the protocol and completes follow-up CRFs. 14. Prepare reports, including but not limited enrollment logs which assists with institutional statistical analysis. 15. Coordinates workflow related to data collection. 16. Implements training of all new Data Coordinators with Nurse Educator. (Preceptor Role) 17. Provides cross coverage to other division on an as needed basis or at the supervisor's request. 18. Ensures that electronic databases contain accurate, complete and up-to-date records of each patient participating in a clinical trial. 19. Reviews source documents for completeness and registers patients to studies. 20. Acts as Principal Investigator's representative as appropriate. This may include communicating with sponsors and their representatives, the IRB, and other medical personnel. 21. Reviews medical record and prescreens patients for clinical trial eligibility. 22. Prepares and assists for sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit. Meets with monitor at least once during each monitor site visit and resolves all issues found during visit. 23. Attends research meetings and conferences as required. 24. Participates in staff meetings and in-service education. 25. 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.). 26. Adheres to the standards identified in the Medical Center's Organizational Competencies. Working Conditions: 1. Ability to sit and concentrate at a computer workstation for a minimum of 4 hours at a single sitting. 2. Lifts a minimum of 5 lbs., pushes and pulls a minimum of 10 lbs. and stands a minimum of 4 hours a day. Education, Knowledge, Skills and Abilities Required: 1. Bachelor's degree in a health related field. 2. Minimum of 5 years of Research Data Coordinator experience. Education, Knowledge, Skills and Abilities Preferred: Licenses and Certifications Required: 1. Certified Clinical Research Professional. Licenses and Certifications Preferred:
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.