Description
POSITION OBJECTIVE
Working with a high degree of independence and under general direction, coordinate major activities in medical and related technical areas. The Clinical Research Coordinator coordinates and manages the major administrative and operational activities of the PROSPECT research registry and related studies. This position is responsible for day-to-day study coordination, participant administration, data and record management, and regulatory documentation to support the successful conduct of longitudinal human subjects research.
The PROSPECT registry is a multiyear longitudinal research program focused on individuals at risk for genetic prion disease. The position supports the research mission by ensuring accurate data collection, continuity of participant follow-up, coordination of external services, and compliance with institutional and regulatory requirements.
ESSENTIAL FUNCTIONS
Independently coordinate major administrative and operational activities of the PROSPECT research registry, including participant enrollment, scheduling, follow¿up tracking, and ongoing study maintenance. Assist in developing procedures, coordinate information with others as needed. (20%)
Coordinate major activities of laboratory/ research and administer informed consent processes in accordance with approved protocols and institutional requirements, including remote consent using HIPAA¿compliant platforms. Ensure consent documentation is complete, accurate, and properly maintained. (10%)
Coordinate and administer remote study assessments and participant¿reported data collection. Review submissions for completeness and accuracy and ensure appropriate documentation and data entry. (20%)
Provide input and recommendation to principal investigator regarding significant developments in research projects, participant status, scheduling challenges, and administrative or procedural issues affecting research activities. Independently resolve routine issues to ensure continuity of study operations. (10%)
Maintain, monitor, and reconcile research databases and records, ensuring accuracy, completeness, and timely updates of participant information, assessments, and longitudinal follow¿up data. Identify discrepancies and take corrective action as appropriate. Perform the most complex quantitative analytical procedures. (10%)
Coordinate genetic testing and genetic counseling services with external vendors and participants, including scheduling, documentation, and follow¿up to ensure adherence to study timelines and requirements. (10%)
Prepare, submit, and maintain regulatory and study documentation, including IRB submissions, continuing reviews, amendments, correspondence, and required reports. Ensure records are audit¿ready and compliant with institutional standards. (10%)
Compile, organize, and summarize administrative and research data to support analysis, presentations, manuscripts, and reporting needs of the principal investigator and study team. Co-author research projects. (10%)
NONESSENTIAL FUNCTIONS
May supervise research assistants and students. Provide functional guidance, training, or work direction to student employees or temporary research staff as assigned. Teach or instruct others in research techniques. (5%)
Order, track, and distribute study-related supplies and materials. (5%)
Perform other duties as assigned. (<1%)
CONTACTS
Department: Frequent interaction with faculty, research staff, and student employees to coordinate study workflows, exchange information, and support research operations.
University: Regular contact with IRB personnel, School of Medicine faculty and staff, University Hospitals staff, and administrative offices to facilitate research activities and ensure compliance.
External: Frequent contact with research participants, family members or caregivers, collaborating organizations, and external service providers to coordinate study participation, assessments, and services.
SUPERVISORY RESPONSIBILITY
May supervise research assistants and technicians.
REQUIREMENTS
Experience: 5 to 8 years of related experience required.
Education: Bachelor's degree in science.
REQUIRED SKILLS
Has knowledge of commonly-used concepts, practices, and procedures within a clinical study administration.
Relies on instructions and pre-established guidelines to perform the functions of the job.
Ability to operate laboratory equipment.
Demonstrated history of successful support, education, and advocacy for all students, aligned with the values, mission, and messaging of the university, while adhering to the staff policy on conflict of commitment and interest.
Ability to meet consistent attendance.
Strong organizational and interpersonal skills required, with attention to detail, accuracy, and documentation standards.
Ability to work independently with minimal supervision while managing multiple priorities and deadlines.
Excellent written and verbal communication skills. Ability to interact with colleagues, supervisors and customers face to face.
Ability to exercise discretion and sound judgment when handling confidential information.
Proficient in data management, analysis, and reporting using advanced spreadsheet functionalities.
Proficiency with Microsoft Office applications and database systems.
Ability to interact effectively with faculty, staff, research participants, and external partners.
Willingness to learn and work with artificial intelligence (AI) tools and technologies.
WORKING CONDITIONS
General office environment with extensive computer use. Position is primarily remote, with occasional on-site attendance required for meetings or administrative activities. As remote assessments will discuss PHI, discretion is necessary during these appointments. No regular exposure to hazardous materials.
Requirements
REQUIREMENTS
Experience: 5 to 8 years of related experience required.
Education: Bachelor's degree in science.
