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.
Education / Qualifications
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.
Experience
