Research assistant / technician
Job Summary: The Associate Project Manager I assists the Project Manager and other senior management in clinical and/or data activities in a limited scope on the N. American portion of clinical research projects in order to assure applicable regulations, standard operating procedures and sponsor requirements are met. This position can be a combination of work from home and in office with limited travel.
- Provides operational support for Clinical Operations
- Assists the Project Manager and other senior management in clinical and/or data activities, on clinical research projects in order to assure applicable regulations, standard operating procedures and sponsor requirements are met
- Performs contract and financial management activities for assigned trials and may act as a point of contact with sponsors for project updates
- Provides input in the preparation and discussion with study team for the staff necessary for project; assist in identification of needed staff and coordination of working schedules and assignments
- Performs site monitoring and data review functions as required
- Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Normally receives minimal instructions on routine work and detailed instructions on new assignments.
- Works under close supervision from supervisor or senior personnel
- Ability to work in a team environment and independently as required
- May be required to work Holidays and weekends
- Contributes to the overall operations and to the achievement of departmental goals
- Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures
- Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations
- Other duties as assigned
Experience / Education:
- Minimum of 1.5 years’ experience in CRO, Pharma, Bio Tech/Device Company working in clinical operations; or equivalent experience
- Bachelor’s degree or HS diploma with commensurate experience
- Extrapolates and applies some decisions from previous discussions to new situations
- Recognizes and consults with supervisors on most project-related decisions, especially those that could have substantial impact on clinical, data quality, or regulatory issues
- Effectively communicates in clear, concise, professional manner with employees and senior management within company and with peer and senior level customer contacts
- Communicates well both verbally and in writing and effectively conveys issues and potential resolutions to team members and supervisors
- Demonstrates active listening and interpersonal communication skills and exhibits ability to lead team using appropriate motivational techniques, conflict management approaches, and consistent integrity
- Good working knowledge of clinical research in an operational setting
- Knowledge of FDA guidelines, ICH, GCP, and other applicable regulations; excellent organizational skills, strong time management skills and the ability to thrive in a stressful environment with multiple priorities
- Demonstrates a high level of attention to detail and the ability to interact professionally with clients, team members, and investigational sites
- Solid knowledge of computers and Microsoft Office Suite of products; experience with tools specific to clinical trial management a plus (e.g. CTMS, EDC, IVRS, eTMF, etc.)
- Approximately 15% or less travel required; must have valid driver's license and be able to rent a car
- Ability to stand or sit for most of the work day
- Must be able to perform some activities with repetitive motion, such as keyboarding
- Must be able to travel for long distances in various methods of transportation (ie. car, airplane, shuttle bus, etc.)
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.