What are the responsibilities and job description for the Study Coordinator II position at Smithers PDS (Pharmaceutical Development Services)?
Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories.
Smithers PDS is seeking a Study Coordinator II to join our team in Ewing, NJ. This position assists the Project Manager in performing study-related critical activities. These activities include: (1) authoring and/or QC of analytical plans and reports, Watson and Excel data retrieval, (2) QC of data tables and reports and all study supporting documentation and (3) identifying issues and deviations that affect the quality of study-related data and communicating these to the Project Manager or appropriate department manager.
This position is paid on a salary basis and is classified as an exempt position. Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting client deliverable commitments. Position is generally eligible for a hybrid work schedule with at least three days on-site once all training requirements have been adequately met and proficient performance is consistently demonstrated.
Salary for range for this position is $60,000 - $75,0000 per year. Salary and job title will be commensurate with experience and qualifications. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental insurance, vision insurance, 401K retirement plan and PTO.
- With input and supervision from the Project Manager, assist in drafting Analytical Plans and Reports to support all phases of the business (Transfer, Validation and Sample Analysis) using Smithers or client specific templates.
- Assist the Project Manager with meeting client deadlines. This requires a complete understanding of the status of each active project and the agreed upon project timelines and deliverables.
- Create data summary tables from Watson LIMS and various Excel spreadsheet formats.
- Reviews run folders, notebooks, and other study documentation.
- Assure that all run folders, data tables and reports move through the internal process including QAU in sufficient time to meet client timelines.
- Assure that all QC and QA findings are responded to in a timely fashion and are complete and accurate.
- Assure that all study related information is archived on date that the report is finalized.
- Assist the Project Manager in supplying data releases, plans, and reports to clients.
- Attend Client Conference calls and provide meeting minutes for client conference calls when required.
- Other duties as assigned.
- Knowledge of GLP.
- Ability to multi-task and participate in multiple studies concurrently.
- Ability to ensure high quality data while working under the pressure of strict deadlines.
- Overtime and weekend work as required.
- Work may require the use of PPE (personal protective equipment).
- Adherence to laboratory health and safety procedures.
- Adherence to Standard Operating Procedures (SOPs) & applicable company policies/ guidelines.
- Adherence to federal and/or local regulations, as applicable.
- Minimum of a Bachelor’s Degree in the Biological Sciences or equivalent experience preferred.
- Minimum of 2 years in a QC/QA role at a GLP, GMP facility, at least 1 of which occurred in an analytical laboratory environment under GLP regulation.
- Immunochemistry experience is preferred.
- Extremely strong competence using Microsoft Word and Excel especially with various formatting features.
- Functional knowledge of Watson LIMS a plus.
- Must be detail oriented, well organized with exceptional communication skills.
- Must have sufficient scientific background to understand scientific concepts of ligand binding assays (biomarkers, PK, immunogenicity, and cell-based assays).
- Must be familiar with all GLP requirements.
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Education
Preferred- Bachelors or better in Biology
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Salary : $60,000 - $750,000
