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Study Coordinator, RTSM Support - United States
Bio Clinica (company)
Posted on : 08 June 2017
Our company is the trusted leader in clinical trial management innovation and therapeutic expertise, is looking for intelligent, creative and dedicated professionals to join our growing technology team! We are company that values technical excellence, teamwork and a commitment to success. We employ cutting edge technology to provide our customers with industry leading solutions and are currently seeking to fill the position of a Study Coordinator.
- Assist with project support and administration for projects utilizing company RTSM technology by:
- Understanding and effectively utilizing the primary RTSM system version used by the client.
- Utilizing other RTSM support tools to manage and maintain on-going clinical studies.
- Supporting multiple studies and customers in various stages of the study life-cycle.
- Working closely with the RTSM Leads (study maintenance managers) on assigned study support tasks to meet project/task timelines.
- Keeping RTSM Lead (maintenance manager) advised of task status and escalating as appropriate.
- Serving as additional point of contact to sponsors, sponsor vendors, sites, etc.
- Resolving or escalating study support issues in accordance with all documented processes, work instructions or standard operating procedures.
- Attending and participating in required sponsor or study maintenance meetings.
- Coordinating, hosting, or recording minutes for internal and external meetings.
- Creating, updating and maintaining study specific documents, including but not limited to, study specific project plans, user guides, and data and parameter change plans into a single version-controlled source.
- Maintaining study specific binder with current versions of study maintenance documents.
- Collecting, documenting, and performing customer requested parameter and data changes in alignment with documented processes.
- Facilitating translations of RTSM system and associated documentation.
- Working exclusively with Unblinding (confidential) data and information.
- Protecting blinded information at all times during both verbal and written communication.
- Creating and maintaining metrics as needed.
- Responding to tasks from the Solutions Engineer (study implementation manager) for study changes and upgrades.
- Keeping manager advised of current issues.
- Providing urgent study specific support after business hours as needed.
- Contributes to overall department communication, cooperation and efficiency by:
- Suggesting improvements to work processes that enhance the quality of team/client support and improve efficiency.
- Creating, implementing and presenting training materials and tools for both internal and external teams.
- Preparing for and participating in internal/external audits and investigations.
- Participating in the creation of audit response documentation as part of Quality Investigations.
- Continuously improving understanding of business and client processes.
- Travel: 5-20%
- Lifting: 0-25lbs
- Other: Computer work for long periods of time
- Bachelor’s degree preferred
Additional skill set:
- Conduct reflects integrity, honesty, and responsibility for decisions and behavior
- Able to handle difficult and stressful situations with professionalism, initiative, logic and good judgment
- Able to apply procedures across an extensive range of scenarios requiring strong problem solving and investigation skills
- Demonstrated ability to manage time and multiple tasks, effectively prioritize responsibilities, and successfully meet deadlines
- Ability to work independently and in group settings, leveraging relationships for the completion of common goals
- Excellent attention to detail and orientation toward meticulous, well organized work
- Strong interpersonal and communication skills, both verbal and written
- Goal oriented
- Experience managing project timelines is preferred
- 2+ years of experience in customer facing engagements
- 2+ years utilizing Microsoft Office Suite or similar tools
- Working with clinical trials and/or within pharmaceutical environment preferred
- Experience with interactive response technologies, drug supply, randomization strategies, or other clinical trials management methods preferred
- Experience working within regulatory guidelines such as ICH, FDA, EMEA preferred