Study Designer Specialist-Administrative support

Study Designer SpecialistAdministrative Support
Greenfield IN

Do you have 1 years of Preclinical Animal Research Study experince along with expertise in software Do you have basic coding skills and looking for a position that will take advantage of your strong Preclinical Aniaml Research knowledge and allow for your passion in software and reporting The Study CoordinatorStudy Design Specialist may be a match for you!

The Study Designer SpecialistAdministrative support will play a key role in transferring of data from current study management and other documentation systems into the new Study Designer Software system. In addition to testing and training on the new platform. This position will assist with coordinating the activities of routine and nonroutine studies in compliance with the appropriate company standards GLP and regulatory guidelines in a timely efficient manner. Youll also be responsible for providing general administrative assistance to Study Directors

Position will require training onsite for 12 months at the Greenfield location. Once fully trained this position is open to a hybrid schedule working 23 days remotely and 23 days onsite each week.

Essential Job Duties:

• Transferring of data and setup of studies in new Study Designer Software system.
• Provides administrative and scientific support for toxicology studies including pre study tasks (e.g. protocol development costing scheduling) monitoring the Inlife progress of assigned studies and interacting with clients.
• Ensures study compliance with the protocol standard operating procedures Good Laboratory Practices and other regulatory guidelines.
• Coordinates the efforts of a study team to become a successful project manager.
• Plans prioritize and manage a workload and the associated responsibilities.
• Serves as a contact along with the Study Director in communication and interactions with other departments and clients with assistance as applicable.
• Maintains complete organized and current study files including study schedule protocol and applicable correspondence.
• Drafts protocols and amendments for Study Director Review and approval.
• Ensures all client comments on protocols and amendments are addressed in a timely manner.
• Initiates and submits costing and scheduling request.
• Schedules and participates in preinitiation and other studyrelated meetings as required and takes and distributes preinitiation meeting minutes.
• Drafts and submits appropriate documents to the IACUC/AWERB for approval
• Verifies the project schedule accurately reflects the requirements of the protocol.
• Monitors progress and status of assigned studies.
• Reviews data and identify deficiencies.
• Compiles data for clients for regular study progress updates.
• Addresses and reviews quality assurance audits relating to protocols and amendments and reports (as applicable) with oversight. Follows up with appropriate personnel to ensure all necessary document/data clarifications are completed in the specified timelines.
• Cohosts client visits.
• Performs QC (peer) reviews on study reports.
• Assists the Study Director in monitoring the financial status of ongoing studies including completion of work scope changes as applicable.
• Independently uses project tracking
• Undertakes other administrative or scientific duties as assigned.
• Assist SD by ensuring that study documentation such as Literature Reviews and Animal Order Forms are in place
• Preparation and checking of CTD tables as required
• Prepare shipping documentation including CITES application requests and any other associated shipping documentation as required per study

Education/Experience/Qualifications

• 1 years of handson work performing preclinical animal research studies at Labcorp. 1 years of work on GLP studies
• Preferred but not required 1 year of Labcorp Early Development Study Coordination experince
• AS Veterinary Technology or related field OR BS/BA in Animal Science Animal Behavior Biology Wildlife Studies Zoology or Related Life Sciences OR 2 years of college courses in Life Sciences field with 2 years of laboratory experience or 2 years of animal handling experience.
• AALAS certification at the Assistant Laboratory Animal Technician level is preferred but not required.
• 1 years of experience using Pristima software 1years of experince with CMS (content management systems) such as Documentum.
• Highly prefer candidate with strong preclinical toxicology experince
• Prefered but not required coding experince

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. Casual PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information please click here.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race religion color national origin gender (including pregnancy or other medical conditions/needs) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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