Covance is seeking a Study Coordinator to join our team in Chantilly, VA.
Duties and Responsibilities
- Drafts protocols, sample analysis outlines (SAOs), amendments and study schedules as appropriate, using proposal outline or client-supplied information.
- Reviews study compliance against protocol, SOP, and regulatory agency guidelines.
- Assists in the development of new report formats as needed.
- Improves processes to increase the efficiency of daily/routine procedures and reporting methods.
- Serves as the primary contact in communication and interaction with other departments and clients as applicable.
- Updates and maintains project tracking systems as appropriate.
- Participates in and assists Study Director/Principal Investigator (SD/PI) 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.
- Assists SD/PI in monitoring study phases.
- Assists with training and mentoring less experienced staff.
- Performs other related duties as assigned.
Education/Qualifications - 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.
Experience - Two years of Study Coordinator or related experience.
- Excellent communication, presentation, and interpersonal skills.
- Excellent attention to detail.
- Efficient in prioritizing and managing time.
EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.