Associate Supervising Study Coordinator

1.0 Job Summary

The Associate Supervising Study Coordinator has the overall responsibility for the technical conduct of a study, as well as for the documentation and reporting of results. The Associate Supervising Study Coordinator represents the single point of study control. The Associate Supervising Study Coordinator will demonstrate an ability to not only perform duties requiring a high level of technical skill, but also show complete understanding of research, the objectives of the research being conducted, and be able to independently organize the equipment and their own time to ensure that all deliverables are met. This position will be able to independently review study procedures and conduct them without supervision. This position will also be able to train and lead other staff in study procedures. The Associate Supervising Study Coordinator will also be able to identify possible flaws in study design and report those flaws to the Scientific Director.

The Associate Supervising Study Coordinator will assist the Facility Operations Manager with CAD-specific facility operations, supervision of assigned Research Technicians, and scheduling of personnel within the CAD Department. The Associate Supervising Study Coordinator will have the capabilities of performing and assisting in most assigned CAD facility tasks.

Responsibilities

2.0 DUTIES AND RESPONSIBILITIES

2.1 Key Activities

• Oversee, organize, implement and conduct various aspects of research studies
• Coordinate and monitor study activities to ensure success and timely completion
• Develop the skills to plan, design, and conduct studies
• Coordinate sample analysis with internal and external laboratories, while ensuring study timelines are maintained
• Review study results and coordinate statistical analysis and reporting of results with technical report writers
• Develop and review protocols and study reports and answer questions posed by sponsors
• Work with internal Quality Control and contractor's QAU to ensure that studies are adequately monitored
• Data entry, quality control and basic data analysis
• Develop and revise relevant SOPs as requested
• Perform technical procedural work as required (basic and advanced)
• Train staff on various procedures as appropriate
• Involvement with internal working groups (e.g., animal care committee, health and safety, etc.)
• Explain techniques to new employees and visitors
• Communicate promptly with Scientific Directors to update on all aspects of a study
• Inform the Facility Operations Manager of department or operational issues or concerns
• Assist in hiring individuals deemed to be appropriate for the positions available based on TPC standards and policies
• Assume functions of various personnel as dictated by staffing requirements for individual studies and training
• Involved in matters pertaining to human resources including performance reviews, corrective actions, accident reports, hiring for staff under HR supervision
• Schedule appropriately trained personnel for tasks in the CAD Department
• Responsible for conducting PMRs for direct reports by setting and monitoring individual objectives and performance against them
• Other duties as assigned

2.2 INTERACTION

Interactions with management and other laboratory staff regarding testing procedures and results. Liaison with Study Sponsor representatives, consulting on study procedures and schedule of events. The Associate Supervising Study Coordinator is responsible for the supervision of Research Technicians as deemed applicable.

2.3 COMMUNICATION

Communications are with all departments and employees within the organization as well as communication with external companies. Collaboration, execution, and reporting of the quality assurance program. Verbal communication is required to request and receive instructions for work, to report on activities, results, problems, and to participate in planning and scheduling of work and equipment use. Written communication is required for accurate and detailed recording of procedures, for reporting results, and for completing documentation. Reading and comprehension of scientific publications, written protocols, and manuals is essential.

2.4 Responsibility For The Work Of Others

The Associate Supervising Study Coordinator will be responsible for the work of subordinates, to ensure industrially acceptable levels of performance and report concerns regarding non-subordinate staff to the Facility Operations Manager and/or Human Resources.

2.5 RESPONSIBILITY FOR THE CARE OF INDIVIDUALS

The Associate Supervising Study Coordinator will be responsible for enforcing company policies aimed to ensure the safety and well-being of TPC employees.

3.0 WORKING CONDITIONS

3.1 ENVIRONMENT

There will be occasional periods of several hours per day exposed to noxious odors from diagnostic materials and/or samples. There will also be the occasional need to work with chemicals in a controlled environment.

3.2 RISK TO HEALTH

There will be the occasional exposure to small quantities of toxic irritant or corrosive chemicals as well as exposure to freezers (-80C) and liquid nitrogen (-200C) while storing, retrieving, shipping, and receiving materials. There will be exposure to zoonotic diseases. There will also be repetitive physical activities.

4.0 Physical Requirements

4.1 PHYSICAL DEMANDS

The demands of this position include: standing, bending, twisting, lifting, carrying liquid containers, carrying boxes weighing up to 20 kg, and daily periods of keyboarding.

4.2 PHYSICAL DEXTERITY

Agility, accuracy, and consistency will be required while handling precision instruments such as pipettes, balances, pH meters, and surgical instruments. Strong fine motor skills in fingers, hands, and arms are essential.

5.0 Qualifications

5.1 EDUCATION

• Veterinary diploma or B.Sc. degree in a relevant field (e.g., Pharmacology, Pharmacokinetics, Veterinary Sciences, Biochemistry) or relevant direct experience.
• CALAS- RLAT Certification encouraged.

5.2 Experience

• Experience within a laboratory environment
• Experience with handling the confidentiality of laboratory and scientific data
• Experience executing administrative strategies
• Proven organizational skills and attention to details
• Demonstrated ability to communicate effectively orally and in writing
• Demonstrated ability to work in a team environment and to meet timelines.

5.3 Knowledge/Skills

• Knowledge of the basic principles of biology, immunology, and chemistry
• Knowledge of the principles of safe handling of potentially pathogenic substances and contaminated materials
• Knowledge of CCAC and OMAFRA regulations
• Knowledge of occupational health and safety practices
• Knowledge of the basic principles of scientific research
• Knowledge and understanding of Transpharmation’s Standard Operating Procedures
• Knowledge of computers, including word processing, spreadsheets, and databases
• Knowledge of therapeutic development regulatory guidelines
• Familiar with the following acts and regulations: ISO Guide 17025 (1990) and GLP (both Code of Federal Regulations and OECD guidelines)
• Ability to work in a safe environment
• Excellent verbal and written communication skills
• Basic knowledge of GLP guidelines