Covance is seeking a Study Coordinator II to join their BioAnalytical team in Chantilly, VA. If you have 2+ years of pre-clinical study coordinator experience and are looking for a path forward to project management, then this is the position for you.
In this role you will draft study documentation in accordance with proposal outline or client-supplied information. Documents include: draft protocols, sample analysis outline, and study schedules. You are also responsible for ensuring that the study is in compliance with SOP, protocol, and regulatory agency guidelines,
Strong verbal and written communication skills are essential, as you interface directly with our clients and well as internal project managers and lead scientists.
Other responsibilities Include:
• Reviews study compliance against protocol, SOP, and regulatory agency guidelines.
• Serves as the primary contact in communication and interaction with other departments and clients as applicable.
• Assists in the development of new report formats as needed.
• Improves processes to increase the efficiency of daily/routine procedures and reporting methods.
• Participates in and assists Lead Scientist/Project Manager with pre-initiation and other study related meetings, including scheduling and leading meetings as required.
• Responsible for report preparation, including table and figure preparation.
• Assists in evaluating data for reports.
• Maintains well documented, organized, and up-to-date study files including study schedule, protocol, and correspondence, as applicable.
• Reviews QAU report audits and submits audit responses for approval as appropriate.
• Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
• Responsible for report production through finalization, including archival of data as appropriate.
• Prepares for and participates in routine client visits.
• Manages data transfer to clients as requested.
•Bachelor of Science (BS) degree in science.
•Experience may be substituted for education.
•Efficient use of word processing software, database, spreadsheet, and specialized software.
•Proficient in concise writing; writing should require little or no external review or edit. •Adherence to grammar, punctuation, composition, and spelling according to company standard conventions.
•Experience on a variety of studies performed in the department and exposure to a diverse client base.
•Knowledge of regulatory agency guidelines.
•Two years of Study Coordinator or related experience.
•Excellent communication, presentation, and interpersonal skills.
•Excellent attention to detail. Efficient in prioritizing and managing time.