Child Neurology Study Coordinator

Opening
Full Time 40 hours Grade 051 Neurology M&D Pediatrics
Schedule
8 AM-4:30 PM
Responsibilities
POSITION SUMMARY :
The Child Neurology Study Coordinator 1 will work on several different research projects within the Division of Child Neurology. The studies include but are not limited to Tourette Syndrome, movement disorders and Batten Disease. The research projects may include observational studies, clinical trials, and multi-center clinical research studies. This role will be responsible for the implementation and coordination of human subject studies including subject recruitment, conducting study visits and subject database management for multiple clinical research studies. Position is in person with occasional remote work.
SUPERVISION AND DIRECTION EXERCISED:
May be responsible for training new staff/student workers as determined by Program Manager/Principal Investigator.
SUPERVISION AND DIRECTION RECEIVED:
Under the direct supervision of the Senior Advanced Practice Provider who assists with research studies, with direction from the Principal Investigator(s).
BUSINESS/TECHNICAL EQUIPMENT USED:
Standard office equipment such as multi-feature ACD or smart telephone, PC, copier, printer, scanner, fax machine, and the like. Uses a variety of basic and advanced business/technical programs/applications. Includes systems such vendor applications such as Microsoft Office, or internally developed databases/systems. Uses OnCore CTMS system, IORA and various sponsor/CRO systems for CRFs.
RESPONSIBILITIES:

• As directed with latitude for independent judgement participates in recruitment, screening, consenting and enrollment of study subjects. Communicates, coordinates and schedules (via mail, email, phone, face to face) study subjects for visits providing study information and confirming appointments. Reviews study site patient databases and records for patients that meet the protocol inclusion criteria. Conducts telephone interviews to screen potential study candidates. Reviews medical chart history with Principal Investigator to verify inclusion criteria are met before enrollment. Participates in developing recruitment strategies.
• Conducts research subject visits for studies in accordance with protocol, coordinating these visits with the Principal Investigator. Ensure research participant adherence with protocol requirements such as taking of medications and/or other interventional activities. Subject visits may include a brief physical, cognitive functions tests, or attending an MRI, depending on the protocol requirements. Coordinator may perform testing such as timed mobility tests and cognitive functions tests, depending on the protocol. Training will be provided in order to implement the protocol's procedures. Resolves questions and concerns received from study subjects, triaging to the Principal Investigator or Coordinator II as necessary. Inputs/regularly updates and reviews all patient information in the patient databases to ensure the most accurate databases possible including sponsor CRFs, Epic and OnCore as applicable. Ensures data is entered in a timely manner and database(s) is up-to-date.
• Understands and provides training on protocols, procedures, documentation, and use of study materials to subjects and team members as appropriate. Ensures compliance, follows up and communicates as needed. Keeps current with study-specific training. Attends training sessions and other educational opportunities related to clinical research in order to keep current with Good Clinical Practice guidelines, federal and institutional policies and laws, industry standards and best practices, and trends in relevant therapeutic areas.
• Serves as the liaison between cross-functional research team, study sponsors, and IRB to facilitate communication, resolves issues (e.g., resolve queries from research visits), and enhance collaboration. Schedules, prepares for, and attends study sponsor monitor meetings in accordance with protocol. Represents the University and Principal Investigator at study meetings as needed.
• Manages the regulatory details for assigned research studies. Prepares and maintains regulatory and study documentation. Manages and submits amendments and continuing reviews for IRB approval. Ensures all regulatory requirements are met and documented.

Other duties as assigned.
QUALIFICATIONS:

• Bachelor's degree, preferably in marketing, communications, life sciences, or health administration; or Associates degree and completion of 6 months in the Human Subject Research Coordinator Trainee program .
• Or equivalent combination of education and experience required
• Proficiency in computer software applications including Microsoft Office programs and electronic data capture (EDC) software preferred. Ability to learn and master existing department applications and future software applications and programs. Candidate should have excellent communication and organizational skills; highly persistent and energetic professional style; self-motivation and drive to reach goals/objectives.

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University's mission to Learn, Discover, Heal, Create - and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled
Pay Range
Pay Range: $18.89 - $26.44 Hourly
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.