Scientist, Study Coordination, Method Validation

Requisition Number: 2961

Position Title: Scientist, Study Coordination

External Description:

SUMMARY:  A Scientist, Study Coordination works under minimal supervision and assists Bioanalytical Study Management Team who oversee the conduct of regulated and non-regulated studies. They assist with study management as directed by the Head of Bioanalytical Study Management, and/or Bioanalytical Study Management Team and serve as a liaison between Bioanalytical Study Management, Study Coordination, Quality Control Reviewers, Quality Assurance Auditors, and Document Coordination staff to coordinate study assignments and ensure all applicable quality control timelines are met.

RESPONSIBILITIES:

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 studies, scheduling, and coordinating to maintain the flow of studies 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 Coordination team members, Study Managers, Quality Control Reviewers, and other departments
• Proven experience in study coordination tasks and study requirements, usually associated with three years on-the-job the experience within the study coordination 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 studies and tasks and have the flexibility needed to adjust to changing priorities and unforeseen events
• Ability to interact professionally and to work independently or in teams
• Ability to promote team work
• Ability to prioritize work and define steps needed to achieve assigned study and task goals

REQUIREMENTS:
 

• Bachelor’s degree, with a scientific focus, and five or more years of relevant work experience required

 

 

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City:

State:

Employment Type: Regular

Community / Marketing Title: Scientist, Study Coordination, Method Validation

Company Profile:

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 is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.