Bayonne Medical Center, Christ Hospital, and Hoboken University Medical Center are seeking Clinical Research Coordinators for our newly created scientific division: CarePoint Health Research Institute.
As a Clinical Research Coordinator at Care Point Health Research Institute, you will work under the guidance of the Principal Investigator, Sub-Investigators, and/or Director/Manager of Clinical Operations to participate in the implimentationon of clinical research projects conducted on behalf of the sponsors at the Institute. You will perform study procedures and transcribe source data to case report forms.
As a Clinical Research Coordinator at CarePoint Health Research Institute, you will also supervise Medical Assistants and be responsible for assisting the Principal Investigator and Sub-investigator in ensuring clinical studies are conducted in compliance with applicable regulations and GCP guidelines.
- Recruiting and screening research subjects to evaluate eligibility for a clinical study by reviewing medical record source documents, inclusion/exclusion criteria, and subjects’ willingness and capability to follow required clinical research procedures, processes, and follow up appointments.
- Obtaining informed consent documentation from research subjects prior to any study-related procedures, maintaining patient screening enrollment logs, and following randomization procedures per protocol, ensuring protection of patients’ confidentiality and privacy during initial and follow up interviews and visits.
- If you are NJ licensed nurse, dispensing study drugs per protocol, reviewing subjects’ diaries and questionnaires as appropriate, and collecting, batching, and shipping specimens as required.
As a Clinical Research Coordinator at CarePoint Health Research Institute, you will also schedule subjects for follow up visits and asses subjects’ compliance with the test drugs on follow-up visits.
You must be able to recognize and report abnormal laboratory values, and, if adverse events occur, you must collect and document this information for evaluation by the investigator. In addition, you will document protocol deviations and exemptions by obtaining and reviewing original source documents (e.g. recordings, scans, tests, and procedure results).
As a Clinical Research Coordinator, you will abstract data from medical records, clinic, consultation, and referral notes to study forms and flow sheets; record data onto case report forms; and maintain source documentation for all case report entries.
- Adhering to HIPAA requirements when transmitting data via fax, mail, or electronically as requested by the sponsor or CRO, and resolving data queries and maintaining files for all study related documentation.
- Contacting primary care providers to discuss and inform patient enrollment and study progress as directed, and meeting regularly with investigator and research team to discuss subject participation and protocol progress.
- Timely notification of the investigator, sponsor and IRB of adverse events as outlined in the protocol.
- Scheduling sponsor monitoring visits as directed by the Sr. Clinical Research Coordinator, preparing case report forms and collecting source documents for sponsor / audit review.
- Meeting with research team during routine visits to discuss case report form completion, query resolution and other protocol-related issues and preparing for and participates in FDA inspections.
- Other duties as assigned.