- Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules with some oversight, using proposal outline or client-supplied information.
- Reviews study compliance against protocol, SOP and regulatory agency guidelines.
- Communicates and interacts with study team, other departments and clients as applicable.
- Assists in the development and maintenance of standard report/table formats as needed.
- Plans, prioritizes and manages own workload and multiple responsibilities.
- Independently use project tracking systems as appropriate.
- Learns to improve processes to increase the efficiency of daily/routine procedures and reporting methods.
- Participates in and assists Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
- Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
- Assists in interpreting and 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. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
- 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 processes through finalization, including archival of data as appropriate.
- Assists SD/PI in monitoring study progress.
- Schedules study phases in coordination with SD/PI and lab operations.
- Performs quality control review of data.
- With supervisory assistance, assures technical staff compliance to SOPs and other regulatory agency guidelines.
- Provides input and participates in project meetings, plans, monitors and guides project work.
- Trains, mentors, and assists less experienced staff.
- Participates in client visits as needed, assists in communicating technical information.
- Participates in process improvement initiatives.
- Effectively plans and utilizes personnel and resources for timely completion of assigned projects.
- Assists in writing reports and protocols.
- Writes SOPs and methods.
- Maintains an awareness of the financial status of ongoing studies
- Serve as the primary contact in communication and interaction with other departments and clients as applicable.
- Serves as a backup PI/SD on project management tasks.
Performs other related duties as assigned.
- Minimum Bachelor of Science/Arts (BS/BA) degree with 2-4 years working experience
- 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 accordingly 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 guidance.
- Proven ability to participate in and assist Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
- Proven ability to manage increasingly complex projects and study designs and/or increased study load.
- Demonstrated capability to manage work for key clients.
- Demonstrated ability to support and be involved in process improvement initiates and endeavors
- Proven ability to plan, prioritize and manage workload and multiple responsibilities.
- Demonstrated ability to independently use project tracking systems as appropriate.
- At least two years related or relevant experience.
- Excellent communication, presentation and interpersonal skill.
- Excellent attention to detail
- Efficient in prioritizing and managing time.
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