This position is responsible for leading and managing day-to-day business development activities, service quality and maintaining high customer satisfaction of investigators. Will manage the team and its work at both the academic medical center and in the community.   The Manager, will oversee Clinical Research Specialists and Clinical Nurse Research Specialists to promote and support high participant recruitment and conduct of clinical research activities within the institution and in community settings.

Position Summary/Essential Duties:

1. Provide administrative leadership for the Research & Innovation Center, develop new business opportunities and, manage those opportunities from industry sponsor site assessment visits through the clinical trial startup process to study completion.  (30%)
2. Oversee Research & Innovation  Center operations including providing clinical input to Research Finance in developing budgets for services, adherence to negotiated budget, allocation of resources, adherence to protocol requirements and customer satisfaction with services.  (30%)
3. Creating and maintaining efficient management and financial control systems, programs, policies, work methods and procedures.  (10%)
4. Manage team in conduct of clinical trial processes to ensure high-recruiting clinical trials in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations. (20%)

Oversee and implement program wide projects, provide training to the team members, and ensure that team members maintain clinical and research certifications and licensure needed for scope of practice.  (10%)

This position is responsible for leading and managing day-to-day business development activities, service quality and maintaining high customer satisfaction of investigators. Will manage the team and its work at both the academic medical center and in the community.   The Manager, will oversee Clinical Research Specialists and Clinical Nurse Research Specialists to promote and support high participant recruitment and conduct of clinical research activities within the institution and in community settings.

Position Summary/Essential Duties:

1. Provide administrative leadership for the Research & Innovation Center, develop new business opportunities and, manage those opportunities from industry sponsor site assessment visits through the clinical trial startup process to study completion.  (30%)
2. Oversee Research & Innovation  Center operations including providing clinical input to Research Finance in developing budgets for services, adherence to negotiated budget, allocation of resources, adherence to protocol requirements and customer satisfaction with services.  (30%)
3. Creating and maintaining efficient management and financial control systems, programs, policies, work methods and procedures.  (10%)
4. Manage team in conduct of clinical trial processes to ensure high-recruiting clinical trials in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations. (20%)

Oversee and implement program wide projects, provide training to the team members, and ensure that team members maintain clinical and research certifications and licensure needed for scope of practice.  (10%)

Education/Expertise:  

• Bachelor’s Degree required.
• BSN with active nursing license and/or advanced degree preferred

Required Credentials, License and/or Certifications: research certification (i.e., SoCRA, ACRP) required (or obtained within 6 months of hire)

Experience & Knowledge:

Requires 5 years of clinical research experience which includes at least 3 years demonstrated management, supervisory or project management experience experience in the clinical research environment, managing trials through the study lifecycle (site assessment, start-up to closure;

Knowledge of project management practices

Special Skills & Equipment Knowledge:

Results-driven, detail-oriented person with strong understanding of the clinical trial lifecycle, excellent customer service skills and the ability to work independently on multiple tasks and manage time effectively.  Strong leadership skills to train and supervise direct reports with effective experience in resource planning.  Ability to work consistently and effectively as part of a high performance work team and collaborate effectively with other Harrington HVI administrative and study teams  Good judgment, initiative and problem solving skills.  Excellent written communication skills and interpersonal and verbal communication skills.  Ability to follow through and consistently demonstrate primary job responsibilities are current. Knowledge of computer operations and demonstrated computer skills in a variety of software environments required (ie Excel, Access, Word, database applications).