What are the responsibilities and job description for the Clinical Research Director/ Chief operating officer position at Salma Mazhar MD PA?
Benefits :
Competitive salary
Dental insurance
Health insurance
Paid time off
Profit sharing
Tuition assistance
Vision insurance
Job Summary
COO works as the primary advisor to the organization's senior management on matters related to research administrative tasks. This role includes facilitation and leads implementation of efficient strategies, compliance with quality standards and patient satisfaction, financial planning and execution, recruitment, performance evaluation and staff training, research marketing, outreach, building relationships with community physicians.
Duties and Responsibilities
Direct interaction with clinic operations, working in collaboration with other leadership to achieve targets.
Monitors, trends and provides action plans for Key Performance Indicators (KPIs) within the Research services operations.
Hire, develop, and motivate research employees to achieve objectives
Ensure regulatory compliance with guidelines, rules and laws that govern clinical research
Plan and supervise the recruitment plans of enrolling clinical trials
Have a deep understanding of all protocols and be available as a resource for all site staff.
Review e-source made by site staff for completeness and accuracy
Coordinate and oversee Investigators and Clinical Research staff trainings and meetings
Assist CFO as needed for clinical research program business operations including finance, budget, and accounts payable / receivable
Achieve financial growth goals and quality measures
Forecast growth and other success factors as established by senior leadership.
Set budgets and enrollment forecasts for sites
Identify areas for streamlining delivery of and billing for Research
Act as primary point of contact for new trial leads, overseeing feasibility assessments and negotiation of budgets and contracts.
Liaison with the research community for new growth initiatives and industry sponsor relationships in an effort to increase the research service line
Draft and execute business plans that meet corporate objectives in targeted accounts through needs assessment and the development and implementation of strategies that achieve mutually agreed upon goals, including both a short-term / opportunity focus, as well as a longer-term focus on the mutual benefits shaping Research services
Consistent with needs assessment and mutual goals, develop and execute regional strategies to accelerate growth, garner account loyalty through resource deployment and collaboration with physicians, internal operations management, executive leadership, training and marketing.
Anticipate and proactively manage business disruptions from adverse events such as shipping impacts from adverse weather, carrier disruptions, system outages, etc.
Cultivate internal provider relationships to foster implementation of research studies.
Effectively lead the design and organization of work and allocation of resources to achieve the appropriate staffing levels.
Demonstrate knowledge of regulatory bodies requirements, inspections, and audits.
Ensure that programs are in place as prescribed by regulatory bodies to ensure compliant operations.
Adheres to all safety policies and procedures in performing job duties and responsibilities while supporting a culture of high quality and great customer service.
Performs other duties that may be necessary or in the best interest of the organization.
Requirements :
10 years of relevant experience as a clinical research management position is required
Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred.
Must have experience managing clinical research site.
Sound knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.
Strong written and verbal communication skills
An ability to consume, absorb, and analyze large amounts of information.
Ability to multitask, work under time constraints, work independently and cooperatively with interdisciplinary teams.
Strong computer skills in appropriate software and related company clinical systems is required
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