Clinical Research Coordinator II

Overview

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 Smelson lab focuses on studying co-occurring mental health and substance use disorders. Much of this work lies at the intersection of addressing behavioral health and social determinants of health needs for vulnerable populations using a public health framework. The RC II will receive hands-on training in project management, data management, and study procedures, and expected to perform various tasks of this nature across projects when applicable and under supervision from their direct supervisor.

Responsibilities

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.

Qualifications

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