Study Director I - MetabolismLabcorp is seeking a
Study Director I - Metabolism to join our team in Greenfield, IN!
Job Responsibilities:The Study Director I is responsible for managing the design, conduct and reporting of studies to meet scientific, regulatory and client requirements in a fast-paced environment. The Study Director is the single point of study control and has overall responsibility for the scientific, technical, and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results. Close and regular liaison with the client is of primary importance.
- Coordinate efforts of the study team.
- Learn to develop protocols and ensure that the protocol, including any changes, is approved and in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.
- Ensure that test and control articles are available, have been tested for identity, etc., and that appropriate technical data are obtained. Also ensure that handling precautions are sufficient to ensure operator's safety and that this information is given to the operational areas.
- Learn to review cost estimates to ensure that all protocol/amendment driven work scope specifications are included in the price estimation.
- Understand financial status of ongoing studies.
- Monitor progress and status of assigned studies. Ensure that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
- Direct preparation of reports, ensure compliance with protocol and regulatory requirements, and submit them to the client.
- Participate in and may host client visits.
Minimum Qualifications:- Bachelor of science degree with 5 or more years of experience in research or Master of science degree with 2 or more years of experience in research
Preferred Qualifications:- PhD degree
- 2 or more years of experience with In vivo Pharmacokinetics (PK)
Additional Job Standards:- Awareness of requirements for working within a GLP, GCP and GMP (as appropriate) environment
- Basic awareness of the drug development process, regulatory requirements and the scientific techniques of standard metabolism studies required
- Strong client relationship building and management skills
- Ability to communicate effectively verbally and in writing
- Strong attention to detail, organization, and time management skills
- Skilled in performing scientific presentations and preparing scientific publications
- Experience in a feeder role for a study director with skills and competencies in the relevant study types
- Previous data interpretation and report writing experience
- Working knowledge of MS Word, Excel, PowerPoint and general IT skills
At Labcorp, you can expect the following:- Innovative Environment: Join a leading healthcare organization committed to driving innovation through internal development to help improve health and improve lives.
- Collaborative Culture: Work in a dynamic, inclusive environment that values diverse perspectives and fosters collaboration.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. For more detailed information, please click here.
- Relocation assistance available
