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Working independently with minimal guidance and direction, assists in the planning and conduct of XXXXX clinical studies. Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and XXXXX Standard Operating Procedures. Able to solve complex problems; considers alternative or new perspectives using existing tools and standard processes. Focus is on the development and management of a subject screening committee to ensure trial enrollment goals are met. May contribute to developing other study related materials; May also provide oversight of additional vendors and committees.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Ensures compliance with protocol and all regulatory policies, procedures and/ or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
Ensures validity of study by identifying/resolving discrepancies and obtaining missing data and tracks study enrollment activities and more complex components of the trial.
Contributes to developing and writing clinical protocols, case report forms, committee charters, and other study aids for investigational products by addressing issues by interacting with appropriate personnel.
Maintains expertise in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.). Serves as a resource for clinical trial regulations.
Mentors and trains new employees. Demonstrates leadership within their organization and provides general leadership direction.
Seeks out opportunities to demonstrate skills and knowledge base to senior leaders.
Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
Supervisory / Management Responsibilities
Works independently with guidance/direction provided by their manager. Strong decision-making skills and responsibilities. Guides other team members in day-to-day activities.
Position Accountability / Scope
Establishes and cultivates a network of internal resources to facilitate completion of tasks. Individual influence as exerted at various levels across the team. Completes daily work to meet established schedule through selfprioritization of tasks. May exercise authority within pre-established limits and approval.
Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.
Bachelor's degree and a minimum of 6+ years of related work experience with a solid understanding of specified functional area, or an equivalent combination of education and work experience.
Minimum Experience / Training
** Experience managing and interacting with study committees comprised of physicians who have appropriate therapeutic expertise.
Broad knowledge and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Learns to use professional concepts and company policies and procedures to solve routine problems. Works on problems of limited scope. Independent decision making required.
** Prefer candidates with experience in Medical Devices
Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include but is not limited to:
Coordinates and lead activities with study specific committees, vendor services, and core labs.
Drafts study related materials such as: patient brochures, patient recruitment material, and presentations.
Drafts protocol summary, annual report, and other study reports.
Drafts informed consent documents and ensures all required elements are included.
Develops for review draft Case Report Forms and associated edit logic.
Assists with site nomination, qualification, and selection processes.
Provides product/protocol specific support and training to internal and external clinical personnel.
In consultation with study management, the assigned field clinical personnel and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study sites.
Reviews and analyzes data and documents for accuracy and completeness. Can lead study team to clean and review data. Creates and processes data queries.
Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits.
Independently reviews site compliance and raises issues to study management. Can lead team meetings reviewing compliance concerns.
Reviews and processes product complaints and adverse events as soon as they are reported.
Mentors less experienced clinical team members.
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