Study Coordinator I

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Function as lead writer for standard study reports.
• Attend study meetings as applicable to assure a full understanding of assigned projects and results, including objectives, timelines, and reporting requirements.
• Participate in client interactions (if applicable).
• Ensure that all protocol and amendment requirements are met.
• Ensure reports meet regulatory and client requirements.
• Generate, format, and/or review report components/text using pre-defined templates.
• Generate, format, and/or review data tables from multiple data collection systems.
• Generation of Common Technical Documents (CTD) and any other regulatory agency summary table requirement (as needed).
• Ability to compile and/or interpret scientific data, meeting with Study Director/PI as needed.
• Provide editorial/formatting review of final study protocols, amendments, and report text (as applicable). Provide comments and/or suggested changes to Study Director/PI.
• Proficient in generating reports in one major area.
• Other duties as assigned by departmental management.

QUALIFICATIONS:

• Education: High School diploma or General Education Degree (G.E.D.), preferred. Associate’s degree (A.A./A.S.) or equivalent from a two-year college, recommended. Bachelor’s degree (BA/BS) or equivalent in science or related discipline, strongly recommended.
• Experience: 1-2 years related experience in a laboratory or scientific research environment. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None.
• Must be authorized to work in the United States without a sponsor visa, now or in the future.
• Other: This position requires analytical thinking skills and a good understanding of scientific processes. Strong interpersonal/organizational skills and attention to detail are required, as well as strong written, verbal, and analytical skills. Must be proficient with spreadsheet, word processing, and publishing software. Familiarity with preclinical study protocols/reports, knowledge of GLP regulations/FDA electronic reporting compliance, and scientific/medical writing and terminology preferred. Ability to adjust priorities to adhere to stringent deadlines. Ability to work with all levels of staff. Ability to interact effectively with diverse personalities and ethnic backgrounds is essential.

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee is regularly required to talk, hear, and type at a computer.
• Able to lift up to 50 Ibs.
• Specific vision abilities required by this job include close vision and the ability to adjust focus.
• Must be able to regularly sit approximately 6 to 8 hours a day.
• Must be able to frequently type an average of 6 hours a day.
• Must perform data entry to and make edits on information contained on a personal computer.
• Must be able to regularly communicate with personnel inside/outside the company as appropriate.

WORK ENVIRONMENT:

• General office working conditions, the noise level in the work environment is usually quiet.

COMMENTS:

• This position may require overtime, weekend, and/or after hours shift coverage, as needed.