Research Coordination-Clinical Interventional/Therapeutic - Military Veterans

The primary purpose of this position is to support clinical studies, including clinical trials, within multiple pediatric specialties according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new studies, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, performing regulatory management, and responding to data queries.

Responsibilities:
Clinical Research Project Coordination (70%)

• Coordinate patient participation in clinical research, including screening and recruiting patients and families, ensuring study eligibility and enrollment, scheduling and conducting research visits
• Data collection and submission for multiple projects, including engaging with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts.
• Specimen management for multiple projects including facilitating the collection of research
  specimens during routine clinical procedures, ensuring high quality processing of research specimens, and coordinating timely and compliant shipment of research specimens to research laboratories
• Facilitate the timely review and reporting of adverse reactions and serious adverse events
• Contribute to the production of research publications or presentations of research data
• Additional study-related activities, as assigned.

Regulatory (20%)

• Prepare regulatory submissions in collaboration with the PI including continuing reviews, protocol amendments, and consent form modifications
• Support the maintenance of regulatory binders and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time.
• Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
• Report Unanticipated Problems according to University policy

Administration and Education (10%)

• Support new project development and study start-up activities
• Support quality improvement initiatives
• Serve as mentor and share knowledge with other study coordinators and study team members
• Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
• Attends local and national study meetings as appropriate

Essential Employees

The successful candidate will be designated as an Essential Employee. Essential Employees are expected to report to campus during a University State of Emergency (reduced operations or campus closure) unless specifically directed by the Department not to report or if directed by civil emergency or medical authorities not to report for health and safety reasons. As an Essential Employee, you must report to campus even if the closure is less than 3 days.

All required qualifications must be included in the application materials

Required Qualifications:

• BA/BS in a scientific or health related field and 2 years research experience OR a combination of education and experience in research to equal 6 years
• Experience as a research coordinator in clinical research, including obtaining informed consent
• Working knowledge of Good Clinical Practices (GCPs), and federal regulations related to clinical research
• Experience with computerized data management, preferably in a health-related setting and including experience with electronic medical records
• Detail-oriented with exceptional organizational, planning and problem-solving skills
• Ability to work independently, as a part of a team and with changing priorities
• Demonstrated ability to maintain deadlines and prioritize assignments
• Excellent written, verbal and interpersonal skills
• During a typical 8 hour shift, a person in this position may be required to stand up to 2.5 hours, walk up to 2.5 hours (including stairs), reach above shoulders, lift up to 10 pounds above the shoulder, and carry packages across campus at waist level.

Preferred Qualifications:

• Experience with computerized data management, preferably in a health-related setting and including experience with electronic medical records
• Demonstrated data management skills, including data collection, data entry, and ensuring data quality
• Specimen management experience including processing human samples and shipping per regulations
• Regulatory management experience including IRB submissions and regulatory binder maintenance