Study Coordinator II - BioAnalytics
We have a great opportunity for aStudy Coordinatoron our BioAnalytical Team in Chantilly, VA.
Lapcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.
In this role, you will be coordinating the activities of routine and non-routine studies in compliance with appropriate company standards, GLP, GCP, GMP, and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient, and quality manner. High volume of data and report delivery.
Candidates given best consideration will have the following skills/experience:
- Proficient in Microsoft Excel and MicrosoftWord
- Highly Organized
- Works Well Independently
- Ability to Multi-task Effectively and Navigate Various Systems
Schedule: Core hours are 9:00am-3:00pm with flexibility on start and end times around core hours.
This position will be a combination of both remote based and on-site the facility.
Essential Job Duties:
- Independently 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.
- Learns to 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.
- Learns to manage increasingly complex projects and study designs and/or increased study load.
- 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.
- Assists with routine client visits as requested. Manages data transfer to clients as requested.
- Assists SD/PI in monitoring study phases.
- Performs other related duties as assigned.
- 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.
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