SEARCH CAREER OPPORTUNITIES

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.

We are a microbiome research laboratory that uses a variety of next-generation sequencing, molecular, and cell biology approaches to understand how diet affects the microbiome and to identify the mechanism by which diet-dependent changes of the microbiome trigger inflammation. We carry out nutritional intervention trials in patients to later validate relevant diet components or specific members of the microbiome as therapeutics both in vitro and in vivo. Our laboratory aims to advance treatment by using the knowledge generated in the bench to the care of the patients in our hospitals. We strive for diversity in science by training scientists from different backgrounds and by including underrepresented members of our community in research; thus our findings can be widely applicable to our diverse community. More information about the lab at: https://www.umassmed.edu/maldonado-contreraslab/

The Clinical Research Coordinator will be responsible for the execution of a clinical study at the University of Puerto Rico.

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

Preferred Qualifications:

Fluent in Spanish
Ability to travel to off-site locations (including Puerto Rico)