Sr Human Subject Research Spec

Opening

Full Time 40 hours Range URG 110 General Neurology Unit

Schedule

8 AM-4:30 PM; OCC WKNDS

Responsibilities

General Purpose:

Under general direction and with considerable latitude to exercise independent judgment, oversees the operations of assigned divisional clinical research programs. Manages and oversees the activities that establish, monitor and maintain human subject research. Manages all aspects of complex studies and projects. Responsible for all phases of project implementation for multiple studies, collaborating with study investigators to plan, coordinate, implement, and monitor research studies, including clinical trials and observational studies. Provides support to the Principal Investigator, Research Administration, and research study staff working as an integral part of the study team. Responsible for the coordination and oversight of regulatory compliance for assigned division(s)/clinical research program. Will independently anticipate, identify, and resolve issues to ensure efficiency. May supervise others.

Responsibilities:

Administrative/Study Coordination:

Serves as a resource to coordinators, provides mentoring, assigns work/monitors workflow, conducts performance improvement, and supports work needs as necessary.

Tracks and monitors metrics associated with study start up, recruitment, enrollment, protocol violations, adverse events, amendments, regulatory filings etc. Monitors the progression of all studies and initiates improvement action when needed. Prepares and presents routine reporting to study team.

Provides data driven estimates related to time and effort, enrollment figures and rates, etc. to assist in appropriate budgeting for studies. Meets regularly and communicates with Administrators on research project operations and budgetary updates.

Responsible for compiling study manual to ensure uniformity of subject assessment and data collection.

Writes with PI guidance study protocols. Writes/creates manuals, including MOP.

Serves as primary contact with data managers to obtain relevant subject data such as enrollment numbers and adverse events.

Regulatory Compliance Activities:

Manages compliance with regulatory and institutional requirements and designs systems and processes to monitor and document routine audits for all divisional studies.

Creates, implements, and manages SOPs for regulatory documentation management and study files across the division. Ensures a high level of quality and compliance by identifying trends and issues and initiating corrective actions. Accountable for all aspects of internal and external compliance, standards of quality, regulatory, and reporting requirements. Serves as liaison between the sites and appropriate entities to assure compliance. Prepares all relevant regulatory reports.

Manages regulatory compliance for multicenter national and international research studies, including preparation of single IRB applications for multicenter US based studies and addressing necessary GDPR issues related to International study sites.

Monitors and reviews all study data through routine monitoring and establishment of controls and ongoing quality assurance. Collaborates with study coordinators, sponsors, and investigators to collect data and establish expectations of timely and accurate completion of case report forms.

Maintains protocols and associated documentation such as enrollment forms, eligibility checklists, adverse event reporting forms and case report forms.

Develops University IRB approved informed consent documents for all protocols per study. Ensures integrity of all study data collected.

Trains and oversees assigned divisional human subjects research coordinators (level 1 and II) on protocol procedures, new test/surveys, and other human subject research and sponsor requirements. Evaluates and monitors effectiveness of training and develops new training methods. Directs preparation of IRB submissions.

Keeps current with all federal, state, sponsor, and institutional policies, laws, SOP's and guidelines. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies for the purpose of implementing, managing and evaluating resulting study changes.

Project Management:

Manages all aspects of study. Collaborates with investigators to plan, coordinate, implement start up and manage research studies. Collaborates with other university departments and contacts external to the university, requiring strong communication and interpersonal skills at a senior level.

Manages in collaboration with PI, preparation of reports to NIH.

Leads and coordinates meetings within study team.

Writes Manual of Operations and develops case report forms for multiple studies.

Recruitment, Retention, & Outreach:

Designs strategy for recruitment and retention of study participants for all active studies. Trains and educates divisional coordinators on the recruitment and retention plan and assists with executing plan.

Builds relationships with sponsors, advocacy groups, community and the institution to assist with strategic growth of the division's research.

Writes/Creates communications and materials to keep key stakeholders informed of divisional research activities. Develops educational materials for patients regarding ongoing studies and opportunities to participate.

Responsible for outreach and education including updates to various websites regarding active research, results, presentations, organization of patient day and associated events across the division.

Share responsibilities with other study team members for the recruitment and retention of study participants.

Financial/Budgetary:

Reviews invoices for clinical trials for accuracy.

Assists with budget and contract development for studies. Collaborates with research administrator to develop budget line items for grant proposals.

Coordinates and monitors financial data and spend categories for budget and variance reporting, and for compliance with all institutional requirements for adequate system controls. Reports variances to research administrator.

Coordinates in purchasing material for study procedures.

Completes required documentation for reimbursements to study subjects, both through URMC and third parties.

Qualifications:

• Bachelor's degree
• 5 years of experience in human subject research coordination; or an equivalent combination of education and related experience.
• Experience as a Human Subject Research Coordinator II
• Knowledge of word processing and data analysis software.
• Experience as a Phlebotomist
• Professional Research Coordinator Certification (i.e. SoCRA or ACRP)

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: $60,431 - $84,603 Annually

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.