Clinical Research Coordinator

Clinical Research Coordinator 3

The Clinical Research Coordinator 3 will manage scientific research projects with minimal oversight. 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. Displays leadership qualities, initiative, and can work well independently and collaboratively. Is proactive in problem-solving, information-gathering, and communication.

Understands when to escalate issues or concerns to leadership, while offering solutions to the issues ages tasks and projects to completion and takes ownership of their quality of work. This at-will position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract. Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.

Responsibilities include:

• Advanced research project management.
• Coordinate programmatic aspects of NIH-funded randomized controlled trials and studies including studies of caregivers of people with dementia, people with cancer, people with cardiovascular disease and diabetes, female sexual function/dysfunction, etc.
• Contribute to the development and implementation of trials; contribute to the analysis of trial data and outcomes;
  Contribute to dissemination efforts and monitor similar or related studies in the field.
• Develop and iterate IRB protocols, manage clinical trials.gov registration, and maintain regulatory compliance.
• Create meeting agendas and lead internal and external meetings.
• Foster and maintain internal and external research partner and clinical site relationships.
• Ensure milestones are met within budget and on time including: tracking data collection progress, identifying deviations from projected accrual plans, directing solutions to course correct, collaborating with research analytics and operations teams to meet goals.
• Collaborate with external vendors to ensure timely progress and fidelity to study protocols.
• Work closely with investigators and other staff to facilitate community engagement efforts, public relations and affairs.
• Work closely with grants and financial management partners to ensure projects progress on time and within budget.
• Serve as a patient educator in the Program in Integrative Sexual Medicine for Women and Girls with Cancer (PRISM), supporting Dr. Lindau in providing specialized care for sexual health problems in female cancer patients and survivors.
• Manage personnel effort allocation in partnership with other project managers and grants and financial management partners.
• Develop progress reports.
• Contribute content and manage efforts related to advancing new funding opportunities.
• Train and mentor junior staff and/or research trainees (including student interns, part-time staff as needed).
• Supervise junior staff and trainees in all aspects of project coordination and management, ensuring effort is adequately allocated.
• Write SOPs as needed.
• Collaborate with other senior research staff and PI(s) to match trainee skill sets and learning objectives to appropriately challenging research activities.
• Oversee and contribute to preparation of project presentations, media and other materials.
• Maintain technical and administrative support for a research project with great independence.
• Analyze and maintain data and/or specimens. Conduct literature reviews. Assist with preparation of reports, presentations, manuscripts and other documents.
• Interact with human subjects, students, and other internal/external collaborators under the direction of the PI.
• Participate in the recruitment, enrollment (includes obtaining informed consent) and retention of human subjects; developing or amending study protocols; developing data collection tools and building databases; providing general administrative support.
• Has general knowledge and experience in research techniques or methods, related technologies, regulatory policies and procedures, and relevant scientific field.
• Accountable for all tasks in moderately complex clinical studies.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks.
• Performs other related work as needed.