Scientist, Study Coordination
Location: Austin, Texas, United States
Requisition Number: 1729
Position Title: Scientist, Study Coordination
SUMMARY: A Scientist, Study Coordination works under minimal supervision and assists the Bioanalytical Study Management Team who oversees the conduct of regulated and non-regulated studies. They assist with project management as directed by the Senior Manager, Head of Bioanalytical Study Management, and/or Bioanalytical Study Management Team and serve as a liaison between Bioanalytical Study Management, Study Coordination, Quality Assurance Auditors, and Document Coordination staff to coordinate project assignments and ensure all applicable quality control timelines are met.
Tasks may include but are not limited to:
- Ensure quality of deliverables including data, reports, and electronic files
- Draft written procedures and templates to maintain a standardized quality output
- Assist in assigning projects, scheduling, and coordinating to maintain the flow of projects and to meet timelines
- Assist with communications with analysts and other personnel involved in conducting the studies
- Assist with cross-department communication as necessary to ensure adherence to current policies
- Assist with the review of data using scientific judgment regarding the quality and integrity of data and records associated with assigned studies.
- Assist with conducting/ensuring the study is in accordance with applicable SOPs, GLPs, study plans, and protocols
- Communicate effectively with all levels of personnel
- Assist in writing, preparation, and review of Sample Analysis Plans, Validation Plans, Analytical Test Methods, reports, SOPs, and protocols
- Follow Worldwide’s safety procedures and guidelines
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Highly developed organizational and time management skills
- Communicates effectively with upper-level management, Study Managers, Project Associate team members, and other departments
- Proven experience in team management/team lead experience, usually associated with three years of on-the-job experience within the project associate role or similar internal role
- Understands Worldwide’s policies, Standard Operating Procedures, and regulatory issues
- Familiarity with the corporate policies, goals, and objectives; normally acquired after three years of on-the-job exposure to Worldwide operations
- Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events
- Ability to use logical inferences to understand the “big picture” and long-term implications of these regulated bioanalyses and their role in drug development
- Ability to interact professionally and to work independently or in teams
- Ability to promote teamwork
- Ability to prioritize work and define steps needed to achieve assigned project goals
- A minimum of a bachelor’s degree, with a science discipline, and 6 plus years of relevant work experience
Employment Type: Regular
Community / Marketing Title: Scientist, Study Coordination
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.