Job Description

The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.
Job Summary: The primary purpose of this position is to perform scientific and administrative support for study direction and study coordination teams. The Technical Study Coordinator II is responsible for assisting with the scientific and administrative tasks associated with coordination of routine and non-routine studies, in compliance with the appropriate company standards, GLP and regulatory guidelines in a timely, efficient manner. This includes initial development of proposal outlines, draft protocols, or other related information needed to assist in the costing process and review for standard inquiries at multiple company locations. General assistance to the Study Coordination team and Study Directors will be an essential part of the role and additional non study specific support may be given to key clients. Additional daily duties may include support of other functions within Safety Assessment. C. Essential Job Duties: List of all essential job duties shown below is intended to describe the general nature of the job and is not intended to be an exhaustive list of all responsibilities, skills and duties.

• Gains knowledge of Safety Assessment service lines and uses resources to facilitate rapid proposal and draft protocol development. This consists of the initial development of proposal outlines and draft protocols to assist in the costing process for standard inquiries and the rapid scheduling of studies at all international sites.
• Gains knowledge of Safety Assessment services and studies and uses knowledge to provide administrative support for toxicology studies, including pre-study and in-life tasks e.g. request form submission.
• Provide administrative backup support for Study Directors on day to day study-specific activities or tasks.
• Prepare shipping documentation including CITES application requests and any other associated shipping documentation.
• Assist with the further development of study protocols and amendments
• Understands protocols, standard operating procedures, Good Laboratory Practices, and other regulatory guidelines applicable to multiple sites.
• Uses project tracking systems.
• Is able to plan, prioritize, and manage a workload and the associated responsibilities.
• May initiate and submit costing and study related forms.
• Process purchase orders.
• May review data and identify deficiencies.
• Undertakes other administrative tasks and duties as assigned.

Experience: Minimum Required:

• 2+ years' experience in a pre-clinical CRO or related industry in a scientific or project management role
• Ability to use several software packages i.e. Word, Excel, Outlook
• Experience and good knowledge of GLP

Education/Qualifications/Certifications and Licenses

• Bachelor's degree in a related scientific field (minimum)

Competencies:

• Demonstrates excellent attention to detail; consistent accuracy
• Demonstrate excellent communication, interaction and responsiveness skills
• Demonstrate ability to create good relationships (internal and external)
• Have a positive attitude to challenging objectives focusing energy towards productive solutions
• Develops proficiency in specific software used in study conduct and reporting.
• Demonstrate good presentation skills (internal and external)
• Demonstrate and promote teamwork
• Effectively manages own deadlines
• Skilled in time management and priority setting; possess a sense of urgency
• Excellent scientific knowledge and understanding of industry requirement
• Excellent knowledge of GLPs, regulatory agency guidelines and Home Office requirements as applicable
• Familiarity with routine study procedures on multiple study types.

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