Director of Clinical Research

Benefits

Qualifications

• •Bachelor's Degree required, or equivalent combination of education and related experience
• •Must be ACRP or SOCRA certified
• •5-8 years of relevant site management, development, and site expansion experience or an equivalent combination
• •Ability to travel as necessary across Innovo site network and to industry conferences (45%)
• •In-depth knowledge of the drug development process
• •Knowledge and ability to apply GCP/ICH and all applicable FDA regulations and guidelines for human subject protection, drug, and device
• •Knowledge of clinical research financial parameters, CTMS, project financial tracking, health system billing, and accounting methods
• •Excellent leadership, communication, and interpersonal skills
• •Proficient in the use of Microsoft Office
• •Excellent organizational and problem-solving skills
• •Effective time management skills with the ability to multi-task and manage competing priorities
• •Expert ability to analyze metrics and information; ensuring activities and strategies are data driven
• •Ability to establish and maintain effective working relationships with physicians, coworkers, managers, and clients
• •Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status
• •Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time
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Responsibilities

• •The Director of Clinical Research is responsible for the development, implementation, and coordination of personnel supporting clinical trial operations for designated sites across Innovo’s site network
• •Directs, plans, and coordinates clinical research activities to ensure goals and objectives are accomplished within the prescribed timeframe and sponsor expectations
• •Oversees recruitment, management, and retention of research staff
• •Also the understanding that although this is a remote role, please be aware that there will be travel to the clinical research sites, up to 45%
• •The Director of Clinical Research is responsible for developing, implementing, and coordinating a team of highly skilled professionals to ensure the successful execution of clinical trials
• •The focus will be on achieving goals and exceeding sponsor expectations while maintaining the highest standards of quality, compliance, and fiscal performance in clinical trials
• •In addition, this position will provide leadership and mentorship to your team and foster a collaborative and growth-oriented environment
• •Lead and motivate a team of clinical research professionals across designated sites of Innovo’s site network
• •Manage staff in accordance with the organization’s policies and applicable regulations
• •Includes planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems
• •Approve actions on human resources matters, as applicable
• •Develop managers within the area of accountability to develop staff along career progression aligned with strategic departmental and corporate priorities
• •Oversees regional talent development
• •Evaluate workload, quality, and performance metrics through regular analysis of data
• •Initiate action plans to improve efficiency, quality, compliance, and fiscal performance
• •Ensures the Innovo site network meets the performance metrics required by the business and provides solutions to meet expectations if needed
• •Implement effective risk management strategies to proactively identify and address potential problems with operational performance, timeliness, and quality of research
• •Directs staffing and resource planning and allocation across clinical trial projects including staffing, training, quality assurance, and site evaluations
• •Directs regularly scheduled reporting to program executive leadership; reviews quality assurance reports generated by the data management core and develops plans with sites for corrective actions, as needed
• •Ability to travel to the sites
• •Performs related duties as required
• •This job operates in a remote environment with routine site visits
• •This role routinely uses standard office equipment such as computers, phones, and scanners
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