Sr Human Subject Rsrch Spec(L) - University of Rochester

Responsibilities **General Purpose:** Under general direction from the Research Program Administrator, with direct supervision from Division Research Administrator, and with considerable latitude for the exercise of independent judgment, manages the technical/administrative, financial, quality, and personnel management functions of the Clinical Research Group in the Division of Pulmonary and Critical Care. Plans, directs, monitors and coordinates all phases of human subject research (which may include multi-site and community-based research, as well as multiple therapeutic areas). Manages, designs, implements and evaluates study changes. May supervise others. **Responsibilities:** Oversight of assigned study personnel including orientation, training, documentation of core competencies, certification mandates, safety/responsible conduct of research education and performance evaluations, including the following tasks: + Manages the day to day communication and shared activities for human subject research studies involving units within and external to the University, issue resolution, and supervision of assigned staff + Completes annual performance evaluation process, in tandem with Research Administrator; ensures fair and accurate evaluation following standards of performance. Provides counseling and constructive feedback for employee development. + Performs QA and supervision of team OnCore entries, research tabs and reports. + Participates in staff recruitment and retention initiatives + Manages coordinator effort reporting activities. + Participates in department wide team building and training activities. Manages the studies and portfolio including the following tasks: + Provides professional direction for the projects. Creates, plans, develops, implements and manages study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas. + Organizes and plans project start–up including working with the sponsor and internal resources (CRC, IDS Pharmacy)on budget and agreement, applying for IRB other ancillary approvals. + Reviews potential projects for feasibility, in terms of staffing needs, recruitment, financial break even analysis and scientific overlap with existing studies + Designs source documents and databases. Prepares documents for study sponsor and regulatory agencies including WIRB, RSRB, NIH, and FDA. + Prepares reports for FDA and IRB. + Evaluates protocols and develops protocols from awarded grants. + Writes informed consent forms. + Assists in grant preparation for submission to governmental agencies. + Provides coverage and back-up for team CRCs (Clinical Research Coordinators) as needed. + Provides leadership in problem solving logistical challenges to assure study objectives are achieved according to protocol and projected time-lines. + Acts as point person for clinical triage as PI is often not readily available on a daily basis. + Uses clinical judgment in reviewing clinical labs and adverse events as well as prepares and reviews Serious Adverse Event reports. + Reviews and responds to data queries. Project Management: + Provides professional direction and oversight for multicenter projects which include providing direction for institutions outside of URMC, participating as subawards. + Maintains and tracks regulatory compliance for multicenter studies and assists in IRB approval and documentation at URMC and other participating institutions. + Tracks and documents research milestones and activities conducted both at URMC and outside of URMC for the purpose of meeting NIH goals and managing external institution invoicing and payments. + Communicates frequently with external institutions to assure compliance with multicenter research activities and provides direction for those institutions in regards to research compliance, training recruitment, invoicing and reporting. + Assists in the training, onboarding and participation of URMC staff/faculty and staff/faculty at external institutions. + Assists in the development and creation of project specific documents used at multiple institutions such as protocols, consent forms, source materials, recruitment materials and database forms. Professional Development: + Obtains and/or maintains clinical research certification. + Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. + Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. + Maintains CITI and Conflict of Interest (COI) certification and renewal as required. + Maintains proficiency in UR-specific research software needed to manage clinical research protocols. + Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards. Assists in helping others in same. + Participates in protocol-related training as required. Complies with Good Clinical Practice and the Code of Federal Regulations: + Performs Division audits for compliance. + Ensures proper study documentation is on file in the investigators’ files for the Sponsor, IRB, FDA or other federal agencies. + Oversees compliance with and effectiveness of Clinical Research procedures; recommends revisions as needed. + Demonstrates initiative in improving operational and financial performance with effective decision-making, planning and implementation skills. + Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures (SOPs), and guidelines. + Keeps current with industry standards, best practices, and trends relevant to research studies. **Qualifications:** + Bachelor’s Degree or equivalent combination of education and experience + Master’s Degree in a health related field + 5 years’ experience in human subject research coordination or relevant work experience or equivalent combination of education and experience + 1 year leadership experience + Demonstrated leadership skills and competency. + Ability to effectively manage complex research protocols/procedures. + Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines and standards. + Proficiency in managing multiple and competing priorities/demands. + Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation. + Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork. + Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients). + Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet. + Possesses a high degree of self-motivation; recognized ability to function independently. 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: $59,197 - $82,888 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._ Apply for Job + Careers + Sign In + New User **Location:** Strong Memorial Hospital **Full/Part Time:** Full-Time **Opening:** **Schedule:**