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Short Description Oncology and Research are specialized and require unique skill sets. Realigning our MD Anderson Research Department at Cooper University Health Care with the MD Anderson Cancer Center at Houston’s recommendation, allows research growth in both the structure and the types of studies we are able to offer our clients to advance care. The role of the Oncology Research Coordinator II provides the oversite of clinical studies in the oncology setting managing treatment trials including Phase 1-1V- multi drug regimens, high toxicity potential immunotherapies, cell therapies.
Research 1.1 Organize, participate, and assist in the preparation of documents needed for the initiation, monitoring, internal and external auditing and study close out visits.
1.2 Coordinates the conduct of oncology clinical trials. Trial assignment is disease specific, allowing specialization to disease site knowledge and expertise.
1.3 Completes and maintains the relevant research training to function in the role- including EPIC training, EPIC billing, CITI, GCP, and Specimen Handling.
1.4 Completes and maintains the oncology study specific training required to work on assigned trials- not limited to electronic data bases, scan portals, lab portals, protocol training and amendment training.
1.5 Active 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.
1.6 Participate in clinic to explain the trial and provide informed consent to the patient and family, documenting the process in the patient’s electronic medical record system, EPIC.
1.7 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).
1.8 Ensure drug accountability and appropriate diary completion. Ensure adequate drug supply and assist Pharmacist with ordering if needed.
1.9 Monitor subjects per protocol requirements and ensure adherence to protocol.
1.10 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.
1.11 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. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission.
1.12 Acts as a lesion between disease specific teams, maintaining and promoting research activities such as reviewing new trials, participating in disease specific conferences, and working with clinicians to work on trial success.
1.13 May act as a mentor to coordinators who have joined the unit with less research experience.
1.8 Ensure drug accountability and appropriate diary completion. Ensure adequate drug supply and assist Pharmacist with ordering if needed.
1.9 Monitor subjects per protocol requirements and ensure adherence to protocol.
1.10 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.
1.11 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. These timelines may be shortened during periods of data lock or in preparation for abstract/manuscript submission.
1.12 Acts as a lesion between disease specific teams, maintaining and promoting research activities such as reviewing new trials, participating in disease specific conferences, and working with clinicians to work on trial success.
1.13 May act as a mentor to coordinators who have joined the unit with less research experience.
Multidisciplinary Tumor Board 3.1 Attends and participates in Disease-Specific Tumor Boards.
3.2 Follows up and oversees if research plan agreed upon at tumor board is relayed to patient and necessary action taken. Also relays the agreed upon research follow up plan in writing to the multidisciplinary and clinical research teams.
3.3 Participates in multidisciplinary rounds and conferences. Helps to coordinate and assure all necessary data is available for multidisciplinary cancer team conference.
Complies with all system and departmental policies and procedures; i.e., completes all related documentation.
4.2 Attends annual mandatory in-services.
4.3 Works efficiently, is flexible and sets priorities.
4.4 Maintains active and current professional credentials.
4.5 Back-up other research staff during vacations, etc. when qualified by education and credentials.
4.6 Performs other duties and functions necessary for the maintenance of efficient, economic and quality operation of the department and system.
4.7 Performs all related duties or special projects as assigned/required.
Experience Required Must have at least 3-5 years of related experience.
Education Requirements Bachelor's Degree preferred