Description

Summary:

This position would serve as the clinical research coordinator for the Center for Inherited Myology Research. This center is responsible for developing disease modifying and other innovative therapies for individuals with muscular dystrophy. In this role, the incumbent works with a group that leads an international network aimed at achieving this objective.

For all clinical research studies assigned, the Clinical Research Coordinator is responsible for coordinating clinical research activities in a compliant and efficient manner from study initiation to close out. Under the direction of the Principal Investigator (PI), collaborates with all members of the clinical research team to ensure all federal, state, university and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept. Core responsibilities are listed below along with other tasks and duties as assigned.

Typical Duties

• Responsibility 1 (30%): Research and Clinical Trial Coordination/Study Conduct
  
  • Independently coordinate study recruitment activities: pre-screening, screening
  • Access allowable data capture/retrieval systems and interact with a variety of health care delivery systems to identify potential study participants
  • Conduct and document the initial and ongoing informed consent process for research participants throughout study participation and follow up
  • Coordinate the enrollment of participants, coordinate and file randomization documents; notifying applicable individuals of registration/randomization (PI, participant, study team, pharmacist, etc.)
  • Support the PI and other study staff in following study participants through all study activities to ensure that the study is conducted in compliance with all requirements
  • Work with PI and program staff to ensure all required study close-out activities are complete.
  • For assigned studies, coordinate clinical research processes and documentation which may include: filing and office organization, creation of job aids, conducting protocol related training, research participant scheduling, ordering of study materials and supplies, and scheduling of meetings.
• Responsibility 2 (25%): Regulatory and Compliance Requirements
  
  • Understand and adhere to all human subject protection and IRB regulations required for clinical research.
  • Understand duty to report obligations related to research conduct, and the appropriate university channels for reporting concerns
  • Participate in meetings with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol and regulatory requirements.
  • Coordinate auditing and monitoring activities for assigned studies.
• Responsibility 3 (25%): Data Management
  
  • Assist PI and study team members in the management of study data for new and ongoing clinical research studies assigned
  • Maintain study files according to GCP guidelines and in audit ready condition
  • For assigned studies, ensure subject data is entered into sponsor case report forms, databases and VCU systems in a timely manner and in accordance with sponsor and university.
  • Review and respond to all queries within required time frames, seeking input from PI's and other study staff as appropriate.
• Responsibility 4 (20%): Clinical Skills
  
  • Complete VCUHS orientation and training modules as required for the department and clinical research projects
  • Conduct applicable clinical activities only as approved and required for each clinical research project
  • All clinical skills must be conducted in VCUHS approved clinical areas only. Any protocol required clinical skill requires current VCUHS competency verification/documentation prior to performing each activity
  • Must maintain all required VCU and VCUHS competencies related to performing research related clinical skills.
  • Cannot perform any tasks that by state or local law require a license to perform, unless such license is on file and approved by VCU and VCUHS
  • Phlebotomy, vital signs, electrocardiograms and point of care testing will be a routine part of the job; hence the requirement for formal clinical education, experience and an active license.