Direct and manage the day-to-day activities of the clinical research office ensuring studies are appropriately planned and resourced and staff are trained and developed to meet the needs of all trials. Proactively manage, track, and report on, performance metrics
location: Wilmington, North Carolina
job type: Contract
salary: $55 - 60 per hour
work hours: 9 to 5
Manage training, planning and preparation of new studies including:
- Supervise and coordinate team activities to ensure that team goals are met and to ensure studies are carried out according to protocol, standard operating procedures (SOPs) and applicable guidelines and regulations and within budget
- Plan logistical activity for procedures as per protocol and ensure thorough resource planning
- Identify risks on study and ensure that actions are implemented to mitigate these
- Ensure study specific training materials, documents, and records are prepared and deliver or coordinate training, dry runs, simulations and tests as required
- Oversee the administration and custody of investigational product and comparator medicines according to standard operating procedures
- Manage staff in accordance with organization's policies and applicable regulations.
- Plan, assign, and direct work
- Appraise performance and guide professional development
- Reward and discipline employees
- Address employee relations issues and resolve problems
- Provide training to new staff members on study-specific topics and new clinical skills
- Ensure compliance with staff training requirements by auditing and maintaining training records
- Approve actions on human resources matters
- Drive quality and process improvement efforts to support control of unit budget, development of the facilities and services and the culture towards a high-performing and efficient team
- Actively control department costs and drive increased profitability by evaluating study logistics and planning, managing and maintaining department resources to optimally deliver on these. Includes stock, equipment (including availability and proper maintenance thereof), space and treatment room allocations, and all process related to efficient staffing and scheduling i.e. ensuring appropriate staffing levels; developing plans for use of available resources; coordinating resources when changes occur and volunteer issues arise.
- Drive the collection of metrics and dissemination of the results and develop and implement plans to address issues and areas of concern.
- Cover weekend, evening and night on-call responsibilities as required.
- Update and maintain skills, training and knowledge of topics related to clinical research.
- Bachelor's degree in a health care or other scientific discipline or educational equivalent, preferred; 3-5 years prior relevant experience or equivalent combination of education, training and experience.
- In depth knowledge of clinical trials and Good Clinical Practices (GCP)
- In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules.
- Effective skills in using MS Windows and Office applications such as Access, Outlook, Excel, and Word.
- Effective written and verbal communication skills including good command of the English language.
- Excellent problem-solving skills. Effective organizational skills.
- Strong leadership skills, and the ability to manage direct reports.
- Ability to pay close attention to detail.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
skills: GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.