Clinical Research Coordinator 2

at  Franciscan Missionaries of Our Lady Health System

As an integral member to the research team, coordinates and implements cancer research activities for Our Lady of the Lake Hospital. Responsibilities include collection of data and specimens, completion of study forms, and timely submission of information to sponsoring organizations. Position requires strong commitment to OLOL’s mission and Catholic health care values. Position reports directly to Cancer Services Coordinator.

• Complies with all regulatory, institutional, and departmental requirements related to clinical research. Performs data collection and data entry for all clinical trial activities by organizing, collecting and monitoring data and reports. Participates in study data analysis. Ensures data quality and integrity. Works closely with physicians and nurses to ensure data is complete and correct. Develops tools to streamline clinical trials process. Increases resources for clinical trial endeavors. Prepares and coordinates IRB submissions appropriate to current OLOL’s IRB policies and procedures. Updates protocols and reports updates to IRB when necessary. Reviews vital data of each patient with physician to determine eligibility for study. Registers patients with research organization. Initiates patient protocol file. Secures all supporting documents for patient file. Complies with data calendar for all protocol patients. Participates in meeting with patient, family and medical staff to ensure informed consent and eligibility. Acts as a witness to informed consent. Schedules and ensures performance of all subsequent patient examinations and testing, according to protocol requirements. Arranges, schedules and conducts follow up contact with patients by telephone and in person interviews. Coordinates with pharmacy, medical records and staff to provide and organize documents for clinical studies. Ensures appropriate recording of investigational drugs and maintains a drug log. Maintains and disseminates a listing of active study protocols and current investigational activities for OLOL. Works with Pathology on tissue patients to ensure appropriate amount of tissue is sent per study requirements. Works with lab and phlebotomist to ensure appropriate amount of blood and urine are sent for studies. Shipment of specimens are done according to IATA guidelines for shipping dangerous goods. Orders investigational drugs for GOG studies (consults with pharmacy the amount of vials, etc. to order). Faxes pharmacy info regarding investigational drug while patient is in office then gets drug up from pharmacy to take to clinic. Works with radiologist to ensure proper documentation is made on radiology reports per GOG requirements regarding tumor measurements. When GOG patient comes in for scheduled test, notifies supervisor of radiologist that RECIST criteria must be meet on these patients. When any new information has been found regarding investigational drug, sends to IRB to add to patient consent for approval and once approved, discusses with patient the new findings and reconsents patient. Attends research related meetings.
• Prolonged periods of standing, walking, or sitting while on duty. Lifting, pushing, and pulling up to 10-15 pounds with or without assistance. Visual and auditory acuity and manual dexterity essential to performing designated duties required. Ability to perform effectively in a stressful and fast paced environment. Ability to pass all required health and other screening tests. Physical conditions are clean, neat and well lit. Maybe subjected to unpleasant sights and odors, stressful situations and hazardous or infectious agents where judgment as to precautions need to be taken is essential. Climate control an ambient temperature variances may be experienced. Exposure to limited amounts of hazardous chemicals or substances and infectious disease processes are a possibility. Hours of duty may be irregular or unexpectedly extended due to emergency circumstances. Direct contact with blood or other body fluids to which universal precautions apply. Personal protective equipment is made available and must be worn.

Education :
Must have a degree in medical records or a related health information field.
Experience:
At least three years of related experience.

• Complies with all regulatory, institutional, and departmental requirements related to clinical research. Performs data collection and data entry for all clinical trial activities by organizing, collecting and monitoring data and reports. Participates in study data analysis. Ensures data quality and integrity. Works closely with physicians and nurses to ensure data is complete and correct. Develops tools to streamline clinical trials process. Increases resources for clinical trial endeavors. Prepares and coordinates IRB submissions appropriate to current OLOL’s IRB policies and procedures. Updates protocols and reports updates to IRB when necessary. Reviews vital data of each patient with physician to determine eligibility for study. Registers patients with research organization. Initiates patient protocol file. Secures all supporting documents for patient file. Complies with data calendar for all protocol patients. Participates in meeting with patient, family and medical staff to ensure informed consent and eligibility. Acts as a witness to informed consent. Schedules and ensures performance of all subsequent patient examinations and testing, according to protocol requirements. Arranges, schedules and conducts follow up contact with patients by telephone and in person interviews. Coordinates with pharmacy, medical records and staff to provide and organize documents for clinical studies. Ensures appropriate recording of investigational drugs and maintains a drug log. Maintains and disseminates a listing of active study protocols and current investigational activities for OLOL. Works with Pathology on tissue patients to ensure appropriate amount of tissue is sent per study requirements. Works with lab and phlebotomist to ensure appropriate amount of blood and urine are sent for studies. Shipment of specimens are done according to IATA guidelines for shipping dangerous goods. Orders investigational drugs for GOG studies (consults with pharmacy the amount of vials, etc. to order). Faxes pharmacy info regarding investigational drug while patient is in office then gets drug up from pharmacy to take to clinic. Works with radiologist to ensure proper documentation is made on radiology reports per GOG requirements regarding tumor measurements. When GOG patient comes in for scheduled test, notifies supervisor of radiologist that RECIST criteria must be meet on these patients. When any new information has been found regarding investigational drug, sends to IRB to add to patient consent for approval and once approved, discusses with patient the new findings and reconsents patient. Attends research related meetings.
• Prolonged periods of standing, walking, or sitting while on duty. Lifting, pushing, and pulling up to 10-15 pounds with or without assistance. Visual and auditory acuity and manual dexterity essential to performing designated duties required. Ability to perform effectively in a stressful and fast paced environment. Ability to pass all required health and other screening tests. Physical conditions are clean, neat and well lit. Maybe subjected to unpleasant sights and odors, stressful situations and hazardous or infectious agents where judgment as to precautions need to be taken is essential. Climate control an ambient temperature variances may be experienced. Exposure to limited amounts of hazardous chemicals or substances and infectious disease processes are a possibility. Hours of duty may be irregular or unexpectedly extended due to emergency circumstances. Direct contact with blood or other body fluids to which universal precautions apply. Personal protective equipment is made available and must be worn