Clinical Research Coordinator Hematology at HCA

We believe our success is dependent on a healthy work environment where you are the core of advancing therapies and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.

As the Bone Marrow Transplant Coordinator your primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and close monitoring while the subjects are on study. You are responsible for all data collection, source documentation and submission of adverse experience reports. You will support enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements.

• You will ensure the protection of study patients by timely adherence to protocol requirements/compliance
• You will attend monthly staff meetings and participate in site initiation visits as required or asked to do so.
• You will be familiar with the protocols on which the patients are enrolled
• You will use the protocol as the only tool to screen, treat, and follow patients
• You will review the study design and inclusion/exclusion criteria with physician and patient.
• You will complete and document screening/eligibility accurately
• You will complete and document the informed consent process accurately and have all parties fully execute the document including HIPAA Authorization
• You will complete the inclusion/exclusion form and standard enrollment form accurately
• You will accurately complete and submit the on-study forms within two weeks of enrollment for investigator-initiated protocols
• You will assess the patient and document findings at each clinic visit while on protocol
• You will document all specific tools required by the protocol (i.e. oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.)
• You will screen every new patient or patient returning to office with scan results and document appropriately on the patient tracking logs
• You will complete the study medication order form accurately and have the physician or nurse practitioner sign orders prior to treatment
• You will ensure that all medications, including antiemetics, are approved by the registrar prior to initiating treatment or when changing medication regimens, such as crossover studies
• You will accurately calculate and document the BSA, creatinine clearance, urine protein: creatinine ratio or any other conversions needed per protocol
• You will document any interaction regarding the patient that occurs while the patient is enrolled on a protocol, including follow-up and survival (this includes home health intervention, pharmacies, study managers, physicians, and clinic colleagues)
• You will ensure that follow-up appointments, scans, or any related procedures are scheduled correctly according to protocol requirements
• You will inform and document appropriate Sarah Cannon colleagues when patient comes off study
• You will accurately complete all data and query requests and submit with source documentation within the timeframe specified by the study manager.
• You will obtain completed and signed waivers prior to submitting forms to enrollment coordinator for investigator-initiated protocols
• You will accurately complete the deviation/violation form as soon as event becomes apparent
• You will accurately completes initial SAE report and submits to the Safety Department within 24 hours of becoming aware of the event
• You will accurately completes and submits follow-up SAE report to the Safety Department within the timeframe allotted by the Regulatory Department.