Clinical Research Coordinator - 138402

The Clinical Research Coordinator supports the Principal Investigator (PI) and clinical research efforts at the UCSD Center for Bleeding and Clotting Disorders. Coordinates and manages primarily clinical trials/observational/epidemiological/ data collection and/or investigator-initiated studies in accordance with GCP, FDA, HIPAA and all required regulatory guidelines, with an emphasis on clinical research studies on bleeding and clotting disorders. Provide all aspects of protocol implementation and management, including budget development and negotiation, regulatory document development and filing, standardization of workflow and techniques for study procedures, recruitment, screening for patient eligibility, retention of study subjects. Responsible for data collection and basic analysis, quality control, ensuring protocol compliance, study forms, monitoring patient treatment and toxicities, laboratory and specimen submission, maintenance of accurate and complete clinical research files and adverse event reporting. Coordinate site visits and study audits. Acts as primary point-of-contact for sponsor, regulatory communications and IRB applications. Other duties assigned as needed.

STUDY COORDINATION

• Organizes, implements and administers data management in clinical trials under disease specific programs through the Office of Clinical Trial Administration (OCTA), which includes institutional, industry sponsored, NIH and national cooperative group studies.
• Accurately enters all study patients into the Velos database and validates visits on study calendar following visits.
• Designs and establishes recruitment strategies to ensure successful trial efforts. Determines patient eligibility for study by requesting, receiving, and recording medical data according to protocol; conducting patient assessment by interviewing and screening patients; contacting referring physicians and abstracting medical reports. Ensures that all protocol requirements for study entry have been satisfied. Complete patient registration.
• Establishes and standardizes study workflow and procedures. Monitors study patients while patients are on treatment phase of each protocol to ensure patient safety and adherence to study protocols, federal, state and University regulations and guidelines of data collection, protection of human subjects, confidentiality and security, and safety monitoring of clinical trials.
• Gathers lab tests results, CT results, pathology/operative reports, discharge summaries, physicians' notes, and outside medical records in order to extract patient data and record data in approved format for study purposes (e.g. case report forms, data summaries). Assists with biobank sample collection and management.
• Initiates follow-up requests for data as necessary and ensure comprehensiveness of individual patient data records.
• Assesses, codes and reports toxicities/adverse events/protocol deviations to MD, Study Sponsor, and Human Research Protection Program (HRPP) and ensure that toxicities are addressed and prevented through protocol-sanctioned dose modifications.
• Differentiates between adverse reactions directly related to investigational drugs and/or treatment as opposed to those unrelated to therapy under evaluation (consult directly with PI as needed).
• Creates case report forms and completes clinical trials case report forms.
• Submits pertinent baseline clinical data, biological samples, and operative reports in compliance with protocol requirements. Ensures specimen collection and storage (centrifuging, extracting, and freezing serum) when required. Performs shipping and handling of specimens as required by protocol.
• Monitors patient participation on study by tracking patient follow-up according to the requirements of specific research study, keeping physicians and other clinical staff apprised of data collection and reporting requirements, arranging and scheduling laboratory, and clinical evaluations for study subjects, and identifying problems in execution of protocol and assisting physicians, nursing staff, and pharmacy staff in rectifying these problems.
• Administers questionnaires and assessments.
• Prepares for and participates in audits conducted by industry, national cooperative group or Compliance Advisory Services.
• Compiles and may perform basic statistical data analysis (new patients, relapses, deaths, admissions, number of transfusions, number of days on antibiotic therapy, etc.) and provides reports as requested by principal investigators.
• Implements standard operating procedures.
• Provides in-service training to nursing staff, PI, and site personnel for study specific procedures.

PATIENT INTERACTION

• Records medical histories from patients and evaluates co-morbid conditions for inclusion in studies.
• Reviews pertinent medical records.
• Records relevant information.
• Evaluates relevance of adverse events to study participation.
• Performs phlebotomy (if Certified Phlebotomy Technician), ECG's, vital signs and spirometry as dictated by research protocol.
• Consents patients for studies.

REGULATORY ACTIVITIES

• Acts as primary point-of-contact for regulatory, sponsor, and CRO communications. Corresponds with the Human Subjects Committee (internal review board) regarding application of protocols, adverse event reporting, and changes to protocols. Interfaces between study sponsor and Human Subjects Committee to reach agreement on regulatory issues.
• Assesses and documents adverse events reporting as appropriate to UCSD Human Subjects Committee, Study Sponsor, and FDA.
• As events occur, conducts detailed interviews with subjects who experience medical and nonmedical problems while participating in the clinical study.
• Assesses the needs of subjects with adverse or serious adverse events with discretion. Continually Communicates these events with PI.
• Interfaces with physicians in other disciplines in the conduct of clinical trials.
• Implements procedures whereby patient information and samples can be obtained and incorporated into the studies.
• Interprets research protocols and coordinates to ensure compliance with goals and objectives of the research study.
• Coordinates and conducts site visits with study monitors.
• Organizes and supervises schedule of clinical and data activities to ensure compliance with protocol.
• Maintains clinical trial invoicing logs and corresponding with clinical trial billing office.

• Experience with research protocols in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

• Experience with laboratory procedures and values and experience in interpreting them todetermine patient eligibility and potential toxicities.

• Experience assisting with clinical technical support duties, working as a clinical research associate, or assisting a clinical research coordinator.

• Experience administering assessment tests and questionnaires as required.

• Experience in patient interviewing to determine toxicities related to protocol management.

• Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.

• Skills at assisting in the interpretation of medical charts, experience in abstracting data from medical records.

• Knowledge of FDA policies regulating clinical trials.

• Clear and effective communication skills, including telephone, in person and writing.

• Good interpersonal skills with ability to interact with diverse groups of staff, research subjects, and Investigators.

• Knowledge of research methods and rules of patient confidentiality.

• Computer skills with word processing, data entry, and email capabilities.

• Understanding of medical terminology for screening and recruitment in the context of a clinical trial of investigational agents.

• Organizational skills and ability to accurately report and present data.

Ability to work independently, prioritize workload, meet deadlines, handle problems, and proposeand implement solution.

• Two (2) years of experience coordinating clinical trials.

• Experience with EPIC electronic medical record system.

• Knowledge of hematology and bleeding disorders. Basic understanding of diagnosis, management,and pathophysiology of bleeding disorders.

• Must be able to work various hours and locations based on business needs.
• Employment is subject to a criminal background check and pre-employment physical.