Lead Clinical Research Spec

Rochester, NY

GENERAL PURPOSE:

Provides leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. Provides mentorship and training to team members and provides coverage for clinical trials leadership as required. Manages multiple studies' day-to-day operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, ensures each study's integrity, and mentors less experienced staff. Monitors and maximizes adherence to research standards, regulatory guidelines, and approved operational procedures. Works closely with study team members and other study sites to ensure study participant safety and adherence to study protocol. Manages study-related administrative and human resources tasks and facilitates across-the- board flow of information, orchestrating study activities, and personnel.

JOB DUTIES AND RESPONSIBILITIES:

  • Oversees implementation of all research projects of the Lab for Innovation in Child Mental Health Care Delivery (ICMHCD) to ensure all projects meet sponsor and regulatory policies and procedures (e.g., create and track multi-dimensional timelines). Prepares weekly, monthly, quarterly, and annual reports of all studies progress and identifies and proposes solutions for any study challenges for the Lab Director.

  • Oversees day-to-day operations of multiple studies, including interfacing with PIs, Co-Investigators, research assistants.

  • Manages study related administrative and human resource tasks, including: (1) developing, monitoring and updating study budgets, expenditures, and carry forward issues; (2) personnel recruitment including developing job descriptions, posting new study related positions, interviewing and recruiting study personnel, working with HR on salaries and offers, arranging office space, and, (3) manages the onboarding of new study personnel and ensures all of their requirements for research participation are met, provides training as needed to new and existing team members.

  • Partners with multiple faculty member principal investigators to ensure protocols developed ensure each study’s integrity, adherence to research standards, and IRB compliance.

  • Develops and shares progress reports relevant to each team. Makes changes to increase efficiency in identified goals.

  • Monitors and maximizes adherence to research standards, regulatory guidelines, and IRB approved procedures and documentation. Lead for IRB submissions and amendments, extensions, study close-outs.

Other duties as assigned

QUALIFICATIONS:

  • Bachelor's degree required.

  • 4 years of relevant experience Or equivalent combination of education and experience required

  • Ability to effectively manage complex research protocols/procedures preferred

  • Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines, 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 preferred

  • Recognized ability to function independently preferred

  • CCRP - Certified Clinical Research Professional by the Association of Clinical Research Professionals (ACRP) within 1-2 years required or

  • SOCRA - Certification in Clinical Research within 1-2 years 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: $63,815 - $95,723 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.

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Location: School of Medicine & Dentistry
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