Sr Clinical Research Spec

Rochester, NY

GENERAL PURPOSE:

We are seeking a highly motivated and experienced Senior Clinical Research Specialist to join our dynamic team focused on advancing health equity for older adults with cancer. The Senior Research Coordinator will play a pivotal role in the execution and management of NIH-funded human subject research projects within the Biomarker Exploration and Aging in Cancer and Health Equity (BEACH) lab, with a particular emphasis on ensuring equitable access to cutting-edge interventions for this population. In addition to overseeing the coordination of research activities, the Senior Clinical Research Specialist will contribute to the development of innovative strategies to address health disparities among older adults with cancer. This role offers a unique opportunity to collaborate with multidisciplinary teams and community partners, driving impactful research initiatives aimed at improving the quality of life and treatment outcomes for this vulnerable population. The Senior Clinical Research Specialist will also manage and supervise other team members, including entry-level coordinators and student employees.

JOB DUTIES AND RESPONSIBILITIES:

Manage all aspects of clinical research projects including:

Patient Recruitment and Study Conduct:

  • Facilitate patient recruitment efforts with a commitment to inclusivity and representation, ensuring that study populations reflect the diversity of older adults affected by cancer.

  • Implement culturally sensitive recruitment strategies to engage underrepresented communities and reduce barriers to participation.

  • Ensure proper closeout procedures for completed clinical trials, including dissemination of findings to relevant stakeholders and communities.

  • Collaborate with research teams to develop strategies for translating study results into actionable recommendations for improving health equity in cancer care.

  • Assist with monitoring the studies regularly for conformity with standard operating procedures and verify data to ensure compliance with requirements of the protocol, IRB, University, and federal regulations.

  • Ensure proper reporting of adverse events to PI and IRB, as needed.

  • Attend and present updates at PI oversight study team meetings.

  • Liaise with the IRB to ensure compliance with institutional and federal regulations.

  • Advocate for procedures that protect the rights and interests of older adult research participants, particularly those from marginalized communities.

Administrative and Management Oversight:

  • Oversee administrative processes related to human subject research, streamlining procedures to accommodate the unique needs and challenges faced by older adults with cancer, especially those from historically marginalized backgrounds.

  • Implement strategies to promote inclusivity and accessibility in administrative practices, such as flexible scheduling and transportation assistance.

  • Develop and maintain a comprehensive workflow process for each assigned protocol and timeline of all tasks to be completed for each study that includes all project phases, material procurement, start-up processes, training and implementing changes where needed.

  • Ensure research staff members understand and adhere to all aspects of assigned protocols, procedures, interventions, and standards for documentation and communication.

  • Train research staff on details of study activities, including inclusion and exclusion criteria, informed consent procedures, process for source documentation and case report form (CRF) completion, and adverse event reporting.

  • Develop and maintain workflow, records of research activities, and prepare periodic and ad hoc reports, as required by investigators and/or regulatory bodies.

  • Supervise and mentor trainees in study development.

  • Supervise and mentor trainees, including research assistants,

  • undergraduate and graduate students, under the guidance of the Principal Investigator.

Study Development:

  • Serve as the primary study coordinator for protocol and data-related questions and issues.

  • Collaborate with the principal investigator and research team to develop robust study protocols and clear and accessible consent forms that prioritize inclusivity and comprehension for older adults from diverse backgrounds.

  • Work with PI and study team in the development of data collection forms, training, and recruitment materials, and determination of what study supplies will be needed and ordered on schedule as outlined at project kick off, evaluating any changes in plans and needs for adaptation.

  • Review and edit the protocol and data forms with a high degree of attention to detail for new projects under development.

  • Develop and facilitate patient recruitment efforts with a commitment to inclusivity and representation, ensuring that study populations reflect the diversity of older adults affected by cancer.

  • Develop culturally sensitive recruitment strategies to engage underrepresented communities and reduce barriers to participation.

  • Provide guidance on research methodologies, regulatory requirements, and ethical considerations, fostering the professional development of trainees in clinical research.

Maintains oversight of study data for the assigned projects:

  • Work with IT and Biostatistical teams to establish appropriate data handling procedures, methods for collection, databases, coding keys, storage, and tracking of data for assigned projects.

  • Provide the PI with accurate reports on status of data for assigned projects.

  • Work closely with PI and biostatistical teams to ensure accurate data analysis and interpretation, incorporating statistical methodologies that account for the unique characteristics of older adult populations with cancer.

  • Prepare comprehensive reports that highlight findings related to health equity, informing practice aimed at achieving equitable cancer care for older adults.

  • Opportunity to conduct data analysis, focusing on addressing disparities in cancer care outcomes among older adult populations.

Other :

  • Maintains current working knowledge of clinical research best practices, updates to federal regulatory, Good Clinical Practice, current industry standards for clinical research and project management professionals by regularly attending training sessions, meetings, and conferences.

  • May require occasional travel to attend meetings and/or conferences (1- 3/year overnight), or off-site visits for participant consent and sample collection.

  • Collaborate with community organizations and advocacy groups to promote awareness of research opportunities and ensure community input in study design and implementation.

Other duties as assigned

QUALIFICATIONS:

Required:

  • Bachelor's degree and 3 years of clinical research or relevant work experience.

  • Or equivalent combination of education and experience.

  • Fluent English language skills (verbal and written).

  • CCRP - Certified Clinical Research Professional by the Association of Clinical Research Professionals (ACRP) within 1 year

  • or

  • OCRA - Certification In Clinical Research within 1 year

Preferred:

  • Ability to effectively manage complex research protocols/procedures.

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

  • Fully adheres to applicable safety and/or infection control standards.

  • 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.

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