Manager, Clinical Research - University of Rochester

GENERAL PURPOSE: The Department of Medicine, Division of Pulmonary Critical Care, at The University of Rochester is seeking a full-time Clinical Research Manager oversee and manage clinical research. The division of Pulmonary Critical Care has a robust research portfolio that encompasses Pulmonary Arterial Hypertension, Lung Cancer Screening, Chronic Obstructive Pulmonary Disease, Sepsis, Air Pollution and Inhaled Toxins, Airway Inflammation and Lung Function in Asthma, Oscillometry in Airway Disease, Pulmonary Fibrosis and Lung Scarring, Pulmonary Embolism and Hypoxemic Respiratory Failure. This Clinical Research Manager is responsible for the day-to-day oversight and management of Clinical Research Projects and Staff in the Division of Pulmonary and Critical Care. They will manage the daily operations, including technical/administrative, financial, quality, and personnel management and monitors research activity to ensure compliance with Standard Operating Procedures and Good Clinical Practices. **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 + Assigns staff to protocols and manages workload + Oversees and facilitates eligibility and screening and study recruitment activities + Performs QA and supervision of team OnCore entries, research tabs and reports. + Completes annual performance evaluation process, in tandem with Research Administrator and or Principal Investigators; ensures fair and accurate evaluation following standards of performance. Provides counseling and constructive feedback for employee development. + Participates in staff recruitment, including review of applications, interviews and hiring, as well as promotion and retention initiatives activities, **Study Start-Up and Ongoing Financial Oversight:** + 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.. + Writes informed consent forms. + Analyzes and confirms all relevant effort allocation of clinical research staff + Tracks and documents research milestones and activities conducted in line with the project goals and manages invoicing and payments. **Manages the clinical trial studies and portfolio within the Pulmonary Critical Care (PCC) Division, including the following tasks:** + Operational assessment of proposed new research protocols + Effectively communicates with the research team, sponsor, data coordinating center, compliance monitors, collaborators, investigators’ academic administrative personnel, and other departments + Provides as a point of contact for PCC physicians + Providers coverage and backup for PCC team research coordinators as needed + Provides leadership in problem solving logistical challenges to assure study objectives are achieved according to protocol and projected time-lines + Assumes leadership in protocol implementation and study progress, keeping investigators appraised of study progress + Performs safety and quality improvement efforts, minimizing risk/safety threats + Prepares for and responds to internal and external audit + Plans and operationalizes strategies to monitor, document, report and follow up on unanticipated occurrences, protocol deviations; develops and implements preventive/corrective actions **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, including ClickIRB and OnCore, 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. **Participates in department specific goals including (but not limited to the following):** + Identified and develops new department specific SOPs. + Updates and revises current SOPs as needed. + Participates in department wide team building and training activities + Works in conjunction with leadership to improve operation and financial performance, utilizing OnCore and other university systems **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 and 4 years of relevant experience required + Master’s Degree in a health-related field preferred + 4 years clinical research or relevant work experience + or equivalent combination of education and experience required + Previous leadership experience preferred + Demonstrated leadership skills and competency preferred + Ability to effectively manage complex research protocols/procedures preferred + Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines and standards preferred + Proficiency in managing multiple and competing priorities/demands preferred + Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation preferred + Fully adheres to applicable safety and/or infection control standards preferred + Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork preferred + Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy for patients) preferred + Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet preferred + Possesses a high degree of self-motivation; recognized ability to function independently preferred. + Experience with University Systems including ClickIRB, Advarra Participant Payments, OnCore, EPIC and eRecord + CCRP - Certified Clinical Research Professional within 1 year required + SOCRA - Certification in Clinical Research within 1 year required 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: $68,765 - $103,147 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:** School of Medicine & Dentistry **Full/Part Time:** Full-Time **Opening:**