Clinical Research Coordinator II

POSITION SUMMARY:

Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Coordinator II is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for complex research protocols related to treatment, ancillary services, and prevention practices. The position will involve approximately 50% desk-work and 50% hands-on patient interaction, covering various neuromuscular disorders such as Amyotrophic Lateral Sclerosis, Adrenomyeloneuropathy, and Facioscapulohumeral muscular dystrophy. The research projects cover everything from biomarker/natural history studies to phase 1 through phase 3 clinical trials. Through these various studies we aim to help uncover the causes of neuromuscular diseases and help test potential groundbreaking therapies for these diseases, such as gene therapies and novel antisense oligonucleotide treatments. We are looking for an individual who is excited to advance their career in clinical research and become an integral member of our team.

ESSENTIAL FUNCTIONS:

Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAA
• Identify, schedule and/or conduct participant study visits, tests and/or interviews/telephone follow up calls
• Ensure accuracy and completion of all regulatory documentation, including local or central IRB and study data
• Conduct preliminary quality assurance reviews of study data
• Assist with financial /operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframe
• Present study status reports related to assigned research projects
• Contribute to data presentations and Institutional Review Board (IRB) processes
• Track and maintain study related information in the data management system within the required timeframe Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs
• Contribute to the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• Responsible for monitoring the inventory of research related supplies
• Document and collect data/ samples for research related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.
• Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines. Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance
• Comply with all safety and infection control standards appropriate to this position
• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices Perform other duties as required.

REQUIRED QUALIFICATIONS:

• Bachelor's degree in a scientific or health related field, or equivalent experience
• 1-3 years of related experience
• Ability to travel off site locations