Clinical Research Project Manager

Clinical Research Manager

The job independently manages the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Provides input into the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University. The job includes management of and research participation in the Bionic Breast project and other research studies involving human subjects. Ensures compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives, and mandates. Analyzes possible solutions using standard procedures. Writes articles, reports, and manuscripts. Assists in drafting presentations on research findings. This position draws heavily and about equally on intermediate to advanced quantitative, qualitative, and textual analysis skills applied in support of studies focused on women's health, aging, and the health of marginalized populations.

Responsibilities include:

• Project management for high complexity clinical studies, including the scientific elements of study planning, monitoring, and execution of investigator-initiated research efforts and owning administrative tasks to ensure timely progress toward scientific milestones and deliverables.
• Ensures project compliance with policies, procedures, directives, and mandates.
• Perform significant role in the design, development and implementation of quantitative and qualitative research studies, including grant writing, survey development, participant recruitment/enrollment/interviewing.
• Recognize abnormal results and varying conditions or procedures to correct problems, set up and perform experiments. Analyze meaning, significance, causes, and effects of the subject.
• Support compliant conduct, regulatory, and administrative activities. Stay current with and manage regulatory processes including IRB, FDA, NIH, HIPAA, CITI, clinicaltrials.gov, Florence portal.
• Responsible for training and supervising research trainees, students and staff. Ensures trainees meet project milestones and ensures completion of trainees' research learning objectives.
• Data collection, preparation, management, and analysis for both qualitative and quantitative analyses.
• Prepare and lead presentations and manuscripts, including as first author and presenter, for the purposes of presentation at scientific meetings and publication in peer-reviewed literature.
• Support compliant conduct, regulatory and administrative activities, including leading development and management of IRB protocols, by liaising with peer experts in these domains.
• Independently tracks data collection progress, identifies deviations from projected accrual plans, directs solutions to correct course, collaborates with research operations lead to ensure data collection progresses on budget and on time.
• Performs and supervises others in literature search, synthesis and citation management, ensuring best practices.
• Accountable for all tasks in complex clinical studies.
• Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.
• Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.
• Performs other related work as needed.

Minimum qualifications include a college or university degree in a related field and 5-7 years of work experience in a related job discipline. Preferred qualifications include a master's degree in a related field, five years of relevant research experience, and knowledge and experience related to women's sexual health and social drivers of health. Preferred competencies include excellent critical thinking/problem solving skills, strong analytic skills, expertise in epidemiology, social science, populations studies, clinical trials and/or community health, experience in NIH grant writing, manuscript writing and writing and implementing human subjects protocols, proven expert level proficiency in Microsoft Word, Excel, PowerPoint, and scientific search engines, demonstrated leadership, interpersonal and relationship building skills, demonstrated ability to work independently or in team in a fast-paced environment, excellent organization and verbal and written communication skills, as well as the ability to work effectively with people from many backgrounds, and ability to work with sensitive subject matter.