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Department:

The Clinical Research Coordinator is responsible for management of Research Studies and Clinical Research Data management.

Research: Under the supervision of the Clinical Research Manager and/or Physician, the Clinical Research Coordinator (CRC) participates in all areas of planning, coordinating and implementing clinical research studies, including regulatory, data collection and entry, and IRB follow-up.  The CRC also assists in the development of other specific research projects presented to, managed, or developed by the SVMHS Clinical Research Department.  Specific responsibilities include: gathering and transcribing data into Case Report Forms, maintaining regulatory paperwork, preservation of investigational product, laboratory supplies and other study-related items; and maintaining database records and reports as needed. The CRC may provide training, project leadership, and quality control oversight of entry level research coordinators.  The CRC will be capable of coordinating clinical trials in any target therapeutic area, with a particular focus on cardiovascular and oncology clinical trials.

Data Management: This individual will be responsible for assisting in the management of studies such as cancer studies sponsored by the NCI, e.g. Eastern Cooperative Oncology Group and others.  The CRC assures effective data screening and management necessary to support external data registry submission, monitoring and evaluation functions, physician data, and review functions for the hospital.  Disseminates information as needed in accordance with established HIPAA guidelines.

This position requires a thorough understanding of management of information, and the ability to interact with a wide variety of ethnically diverse people, including patients, their families, physicians, financial staff, clinical staff and information systems. Utilizes clinical knowledge and assessment skills to identify and screen potential research patients using established criteria. Enrolls and maintains records of all clinical research patients.

• Demonstrates the ability to coordinate Research and Data activities in a hospital or other setting independently. 

• Collaborates with Physicians, clinical staff, IRB and Medical Staff Office and clinical trial sponsors.

• Utilizes positive communication and collaboration skills to affect conflict resolution and teamwork. Establishes working relationships with physicians, nurses and staff.  Assures clinical staff education on ongoing clinical trials.

• Following Good Clinical Practice (GCP) guidelines, facilitates physiological, psychosocial and spiritual care of the patient within the guidelines of human subjects protection.

• Assists in the coordination of pre-study activities by submitting required documentation, obtaining and maintaining study device/medication inventor, timely completion of required study training and participation in site visits.

• Assists with the collection of required documentation for site activation and assists with ongoing study monitoring as well as study closure activities.

• In collaboration with the investigator, initiates, manages, and participates in discharge planning and/or patient/family teaching included in a clinical trial.

• Ensure complete and accurate data is collected, calculated and documented within specified timeframes.  Ensures data security, confidentiality and preservation for the control and use of cardiovascular research and data-related information.  Demonstrates timely resolution of data queries.

• Interprets clinical information including assessments, laboratory and other test results to accurately record data for registries and research studies.

• Ensures accurate inventory accountability of investigative devices or medications at clinical sites.  Collaborates with ancillary departments to maintain drug and/or device accountability logs.

• Prepares accurate and timely monitoring reports to study management and follow action items though resolution.  Assures accurate and complete data abstraction.  Participates in data audits to assure compliance and accuracy of data.

• Collaborates with the investigator to ascertain study patient eligibility for a clinical trial, including evaluation of assessment, laboratory and other clinical findings according to study protocol and in adherence with FDA, IRB and other regulatory guidelines. Ensures scheduling of all procedures required to assess for adverse events and disease response to the study intervention.

• In collaboration with the investigator, assess patients for adverse events and then documents and reports these findings in a timely manner per hospital, IBR, FDA and sponsor policies. 

• Evaluates disease response results and physical assessment data in conjunction  with the principal investigator to determine response per the protocol.

• Identifies vulnerable patients who required increased nursing assessment and management in addition to the clinical trial requirements.

• Supports and evaluates patient adherence to the protocol by utilizing various methods to assist with documentation, patient education and study agent/medication return.

• Using clinical knowledge and assessment skills assists with data and quality management activities and analysis of clinical information, as required. 

• Assists with compilation of investigational device/drug complaint documentation. 

• Applies legal and ethical principles, polices, regulations and standards for the control and use of clinical research and data. 

• Serves as liaison between medical staff, staff, and sponsor’s clinical research staff.  Provides site feedback or input to appropriate departments. 

• Attends clinical research related meetings in house and other necessary study planning meetings as scheduled.

• Contributes to ongoing Standard Operating Procedure (SOP) review and development. 

• Participates in training and orientation of new employees. 

• Contributes to cost effective patient care by monitoring use of time, equipment, and supplies.

• Keeps supervisor informed of changes in work schedule and/or workload and communicate schedule to study management.  

• Interfaces with representatives from other key functional departments as necessary.

• Performs other duties as assigned.

Education:   A minimum of a bachelor’s degree required.

Licensure:  Certified Clinical Research Coordinator (CCRC) by the Association of Clinical Research Professionals (ACRP) or by the Society for Clinical Research Associates (SoCRA) required.  New hires/transfers have four (4) years from date of hire/transfer to obtain CCRC certification.   Current BLS/Healthcare Provider status as per American Heart Association standards required.  New Hires/Transfers have a 6-month grace period to obtain BLS certification and must continually remain current.   Current CITI Training certificate of completion required.  Current IATA approved course on Shipping & Handling of Dangerous Goods required. New hires/transfers have a 3-month grace period from date of hire/transfer to obtain CITI and Shipping & Handling of Dangerous Goods certifications and must continually remain current.

Experience: Minimum 3-5 years of clinical trial experience, preferably working with patients on the site side of clinical trials (as opposed to industry).  One year of experience managing research and/or data projects preferred.  Experience in data entry and ability to work in multiple proprietary programs preferred.

Pay Range: The hourly rate for this position is $30.17 - $36.20. The range displayed on this job posting reflects the target for new hire salaries for this position

Job Specifications:

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