Director of Clinical Research

Description

JOB SUMMARY

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%.

Responsibilities

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.
  
  

Qualifications

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
  
  

BENEFITS (for Full-time)

• Competitive salary
• Health insurance
• Dental insurance
• Disability insurance
• Life insurance
• Paid time off
• Vision insurance
  
  

WORKING CONDITIONS

This job operates in a remote environment with routine site visits. This role routinely uses standard office equipment such as computers, phones, and scanners. 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. Occasional evening and weekend work may be required as job duties demand.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities.

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.