- Responsible for assisting the clinical pathologists (remote) in organizing and reporting all aspects of the clinical pathology portion of onsite and cross-site studies.
- Works closely with others to ensure the integrity of the data.
- Maintain study documentation.
- Performs QC review of data.
- Responds to QA inspection report findings and ensures all necessary report and data corrections are made.
- Maintains and expands on working knowledge of regulatory and SOP requirements along with other guidance documents. Applies knowledge to ensure data integrity.
- Oversees outsourced data entry into data capture system. Ensures data is received and reported properly according to protocol requirements.
- Informs Study Director, Principal Investigator and/or management of any problems and/or deviations that may affect the integrity of the data and participates in corrective action of problems.
- Promotes a cohesive team environment.
- Demonstrate excellent written and verbal communication skills.
- Maintains a clean and safe work environment.
- Manages a full study workload with complex or specialty study designs by adhering to report preparation schedules and prioritizing tasks. Identifies and resolves changes to established study schedules to ensure client deliverables are met.
- Assists in evaluation of data for incorporation into written reports.
- Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
- Assists in writing reports, methods, protocols and SOPs.
- To be responsible for toxicology data transfer into Pristima according to the required turnaround times.
- To assist reporting section in carrying out second entry demographics after the first stage has been completed by Sample Management and updating the ClinAxys II system where necessary. To make sure that all relevant request forms are present and checked.
- To inform the clinic or external clients of any ‘alert’ results, and any confirmations required.
- To learn study set-up in ClinAxys II for both Clinical and Toxicology studies as back up.
- To prepare Master Setup forms for Toxicology for CPS and Sample Management.
- To assist with queries from both internal and external clients.
- To check study setup for the CPS Co-ordinators.
- To be aware and understand the weekly schedules required for the CPS laboratory.
- To be fully trained in CPS/Global Archiving procedures and assist in process as and when required.
- To be responsible for the creation of data tables within Tox Reporting.
- Reviews study protocols against the CMS schedule to ensure accuracy.
- Reviews study protocols against the Pristima schedule to ensure accuracy
- Performs other related duties as assigned.
Some college coursework preferred.
- Experience with technical writing or data tabulation, including working with complex study designs.
- Proficient in basic office software (e.g., Microsoft® Office Word and Excel, Adobe® Acrobat®).
- Attention to detail, time management skills, and organizational skills.
- Excellent customer service skills.
- Knowledge of GLP/GCP and regulatory requirements is advantageous.
- Working knowledge of LIMS system (e.g. ClinAxys II) and/or Tox Reporting is desirable.
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