Title: Study Assistant
Location: Concord, OH (on-site)
Reports To: Study Support Team Leader
Company
Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position Summary:
We are seeking a highly-motivated, detail-oriented team member to support client-driven projects. The successful candidate will be an active member of the Study Support Group and will assist Study Directors on assigned studies with general client needs, drafting and issuing protocols/protocol amendments, preparing subreports, running Provantis data tables, and reviewing study data all in compliance with appropriate SOP, Protocol, and Regulatory Agency guidelines.
Roles and Responsibilities:
- Generate Provantis data tables and create PDFs of tables for reporting
- Draft subreports (Ophthalmology, Anatomic Pathology, Clinical Pathology, ECG), protocols, and protocol amendments.
- Review study data, data binders, and documents generated by Study Directors/Study Support as needed.
- Assist with drafting deviations as they arise
- Update Toxicology Project Management system as milestone tasks are completed.
- Review and edit grammar, styles, typefaces, and formatting based on report writing style guidelines for all generated documents.
- Reviewing Locomotor Activity Data spreadsheets and ECGs.
- Data entry into Provantis for various studies
Education and Requirements:
- Associate’s or Bachelor’s Degree preferably in Life Sciences, communication, English, or similar related discipline.
- An equivalent amount of education and/or experience may be accepted as a satisfactory substitute for the specific education.
- Willing to train individuals with correlating background, education, or skills.
- Proven ability to successfully work in a team environment.
- Excellent oral and written communication skills.
- Basic computer knowledge (e.g. Microsoft Word, Excel, Adobe Acrobat)
- Experience with Provantis or similar LIMS software is a plus.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and generous benefits package including health and dental insurance, a 401(k) plan, health insurance, short and long-term disability insurance, life insurance etc.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Skills Required
- Associate's or Bachelor's Degree in Life Sciences, Communication, English, or related discipline (or equivalent education/experience)
- Proven ability to successfully work in a team environment
- Excellent oral and written communication skills
- Basic computer knowledge (Microsoft Word, Excel, Adobe Acrobat)
- Experience with Provantis or similar LIMS software
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
