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Clinical Research Coordinator II

Company: The Cooper Health System
Location: Camden
Posted on: September 16, 2021

Job Description:

One of our large healthcare clients is looking to hire a Clinical Research Coordinator II position in South Jersey for a leading cancer center. The Center takes a disease-site, multidisciplinary approach to cancer care, with an entire team of cancer experts working together to provide comprehensive, collaborative care for each patient. This individual will hold a variety of duties including:

-Assist with initiating study procedures for clinical trials

-Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits

-Coordinate the conduct of complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I IV clinical trials

-Complete relevant training to function in the role including but not limited to electronic databases, and processing/shipping specimens

-Be actively involved in planning and implementation of patient recruitment into studies; reviewing medical records of upcoming new and return patient clinic visits and discussing with investigators, reaching out to potential referring physicians, approaching potential subjects in the office or speaking to them by phone, asking pre-screening eligibility questions, etc. and document in the electronic medical record system, EPIC.

-Participate in clinic to explain the trial and provide informed consent to the patient and family, documenting the process in the patients electronic medical record system, EPIC.

-Develop, schedule and oversee subject visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (GCP) (e.g. scheduling subject visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator (documenting in EPIC any patient reported symptoms and forwarding to the appropriate clinical team), monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities).

-Ensure drug accountability and appropriate diary completion.

-Ensure adequate drug supply and assist Pharmacist with ordering if needed.

-Monitor subjects per protocol requirements and ensure adherence to protocol.

-Show vigilance in patient safety, protocol compliance and data quality.

-Organize and maintain all documentation required by the sponsor or CRO per GCP includes source documentation (including the electronic medical record system, EPIC), case report forms, and research charts.

-Collect, review and report timely, valid, accurate study data.

-Obtain records required to complete case report forms.

-Maintain clinical trial databases by completing case report forms within 5 business days of subject visits and resolving data queries within 10 days of issuance.

-Knowledge or experience in oncology

-MA or RN or Phlebotomist
-Bachelors Degree (Strongly Preferred)

-Minimum 3-5 years of research experience required with practical experience coordinating the day-to-day activities of multiple research projects simultaneously

-Effective verbal and written communication skills

-Basic understanding of Microsoft Word, Excel, Outlook

Keywords: The Cooper Health System, Camden , Clinical Research Coordinator II, Other , Camden, New Jersey

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