Clinical Research Coordinator II

POSITION SUMMARY:

Our research team conducts an array of studies related to addressing social disparities and perinatal and pediatric care. We work with directly with families with social disadvantage, including families with limited English proficiency, families of minoritized race/ethnicity, and those with low-income. We do an array of clinical and health services research using qualitative and quantitative methods. We do observational and interventional studies. We are seeking a Clinical Research Coordinator I to join our growing, passionate research team and work under the direction of the Principal Investigator (PI) or designee. Tasks will involve a large array of procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for research protocols related to treatment, ancillary services, and prevention practices. Our team is seeking a highly motivated individual with an interest in social determinants of health and addressing disparities in healthcare.

ESSENTIAL FUNCTIONS:

Obtain consent of research participants from English- and Spanish-speaking families in the UMass Memorial Medical Center neonatal intensive care unit in accordance with the IRB approved protocols and all applicable regulations including HIPAA
• Assist with recruiting, screening, enrolling, and terminating study subjects
• Ensure accuracy and completion of all regulatory documentation, including local or central IRB and study data
• Communicate with multidisciplinary clinical and research team members both within UMass Chan and with external partners
• Document and collect data and/or samples for research related procedures performed during participant study visits, including qualitative interviews
• 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 and participate in drafting annual NIH reports
• Contribute to data presentations and Institutional Review Board (IRB) processes, including multicenter reliance agreements
• 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), including electronic surveys, chart abstraction forms, and randomization modules
• Translate study documents
• 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
• Excellent communication skills and cultural competence
• Experience with qualitative interviewing is preferred, but not required
• Fluent in Spanish