Clinical Research Coordinator 1

University of Miami Miller School of Medicine • Miami, FL

337d

About The Position

The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Clinical Research Coordinator 1 to work at the UHealth Medical Campus. The Clinical Research Coordinator 1 will work as a clinical research coordinator on both investigator-initiated and sponsored research projects focused on amyotrophic lateral sclerosis (ALS) and related disorders. The work will include both observational studies and clinical trials.

Requirements

• Bachelor's degree in relevant field required.
• Minimum 1 year of relevant experience.

Responsibilities

• Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols.
• Maintains enrollment procedures according to the protocol.
• Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
• Performs moderate to complex research tests/experiments and adapts procedures for quality improvement under supervision.
• Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
• Assist the PIs in developing UM protocols for submission to IRB, including but not limited to the submission of required documentation to the UM/JMH IRB to ensure successful approval of research protocols.
• Maintenance of any reporting and other requirements by the IRB.
• Administer informed consent forms for patients on drug studies.
• Develop, review and submit required documentation to the UM/JMH IRB to ensure successful approval of research protocols.
• Maintain any reports and other requirements by the IRB.
• Interact with various sponsoring agencies and their representatives, on issues regarding ongoing protocols requiring occasional visits to supporting agencies and national meetings.
• Relate information back to the Division.
• Coordinate patient recruitment and screening procedures in inpatient and outpatient settings.
• Obtain necessary medical records, schedule patients for pre-study screening, and maintain a study patient list.
• Coordinate research related activities between departments to accomplish goals of studies.
• Develop and manage the following procedures as they pertain to research studies and patients.
• Perform necessary study evaluations.
• Complete patient data forms; collect results from outside laboratories, etc. and complete data into case report forms.
• Maintain pool of study candidates and ensure their availability.
• Contact patients by telephone as required by the PI for clinical follow-up for requirements and adherence to research protocols.
• Complete the medical chart and log-in of patient's vital signs, including weight, temperature, pulse rate, respiratory rate and blood pressure into case reports.
• Collect vital signs, lab specimens (blood, urine, etc.).
• Prepare lab samples for shipping.
• Coordinate the necessary testing for patient evaluations per physician's orders and study protocol requirements.
• Process and ship lab specimens to central lab as required by protocol and maintain updated study kits and supplies and maintain general laboratory supplies.
• Offer assistance and provide information to help patients with protocol procedures.
• Assist in keeping accurate records of concomitant medications and study medications as per study protocol requirements.
• Maintain patients chart with clinic notes; up to date reports of laboratory results and change in treatment.
• Perform other duties as assigned by PI within established policy.

Benefits

• Medical
• Dental
• Tuition remission

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Hospitals
• Education Level: Bachelor's degree