Sr Clinical Research Coordinator 2

Job Summary

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 leading research activities and management of 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

• Perform significant role in the design, development and implementation of quantitative and qualitative research studies, including grant writing, survey development, participant recruitment/enrollment/interviewing.
• Perform 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.
• 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.
• Perform 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.
• Conducts and supervises others in literature search, synthesis and citation management, ensuring best practices.
• 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.
• Support compliant conduct, regulatory, and administrative activities, including leading development and management of IRB protocols, by liaising with peer experts in these domains.
• Stay current with and manage regulatory processes including IRB, FDA, NIH, HIPAA, CITI, clinicaltrials.gov, Florence portal.
• Ensures project compliance with policies, procedures, directives, and mandates.
• Responsible for training and supervising research trainees, students and staff.
• Ensures trainees meet project milestones and ensures completion of trainees’ research learning objectives.
• Manages the daily administrative and technical activities in a single highly complex, large clinical trial or multiple moderately complex, concurrent clinical trials.
• Designs and guides internal and external audits and manages external surveys.
• Implements Good Clinical Practices (GCP) and all relevant current local, state, and federal laws, regulations, policies and procedures.
• Develops and implements consistent standards and protocols.
• Solves complex problems relating to data management and the analysis of large administrative datasets.
• Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.
• Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience.
• Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.
• 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

Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline. Certifications: ---

Preferred Qualifications

Education: Master in related field (health services research, clinical research, public health, epidemiology, etc.). Experience: Five years of relevant research experience. Knowledge and experience related to women’s sexual health and social drivers of health.

Preferred Competencies

• Excellent critical thinking/problem solving skills.
• Strong analytic skills as well as proficiency in STATA, R or equivalent programs required; qualitative data analysis using ATLAS-TI and similar qualitative software packages.
• Expertise in investigator-initiated clinical trials, community- and population-based trials and other studies, clinical epidemiology, health services research, patient-reported outcome measure development.
• Experience with successful NIH grant writing, manuscript and presentation writing and writing and implementing human subjects and regulatory 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.
• Ability to work with sensitive subject matter.