Study Coordinator I

About The Role

The Study Coordinator Isupportsand coordinates the planning execution and reporting of nonclinical studies under the guidance of Study Director(s). This roleis responsible forstudy administration scheduling documentation compliance monitoring and cross-functional coordination to ensure studies are conductedin accordance withprotocols standard operating procedures (SOPs) and regulatory guidelines.

What Youll Do Here

• Assistwith the preparation review and/or distribution of study protocols and amendments; with experience may independently draft study documentation.
• Coordinate and/orparticipatein protocol review pre-initiation and study-related meetings.
• Review study schedules for data collection within the electronic data capture system. Review updated schedule changes as a result of Amendments/Amended Protocols as necessary based on site structure.
• Assist in the creation review and maintenance of study planning documents (e.g. Project Review Forms or study outlines) under guidance based on site structure.
• Assist with preparation and maintenance of study notebooks study forms and other necessary materials for studies based on site structure.
• Support and coordinate day-to-day study activities across functional departments to ensure alignment with study plans
• Track study progress milestones and deliverables; communicate status updates to Study Director(s) and stakeholders (i.e. In-Life personnel study support groups sponsors).
• May review study data records and processes for accuracy completeness and compliance with protocols SOPs GLP and regulatory requirements. Identifydiscrepancies coordinate resolution of data issues and escalate deviations toStudyDirector(s).
• May generate data tables for inclusion in reports based on requirements of the study. Perform data verification as needed based on site structure.
• Provide coordination for assigned studies from initiation through finalization based on site structure with increasing responsibility over time.
• Support orassistin monitoring in-life study activities asappropriate. Support ongoing compliance monitoring throughout the lifecycle of the study.
• May assist in the preparation compilation and formatting of study reports including drafting sections (e.g. Materials and Methods) and peer review process based on site structure.
• Collects and collates report components for the final report under the guidance of the Study Director utilizing electronic publishing tools based on site structure.
• Maintainaccurate organized and audit-ready study documentation including study files schedules and correspondence.
• May support archiving and preparation of studies for finalization.
• Assistwith quality assurance activities which may include audit preparation and response coordination.
• Support Study Director(s) in coordinating and preparing for client interactions and visits based on site structure. May serve as a key point of contact for internal communication across departments for assigned study activities.
• Provide coordination for short term acute non-GLP studies from study initiation to finalization under the guidance of the Study Director. May also be responsible for coordination for GLP studies.
• Provide backup support to Study Director(s) as needed including communicating study status to stakeholders.
• May prepare and verify sample manifest and coordinate shipping and inventory of samples.

What Youll Need to Succeed

• A Bachelors degree or college coursework in a scientific discipline with 0 - 1 years experience in a scientific environment or an equivalent combination of education and experience.
• MS Office Suite
• Ability to read and interpret technical documents and industry specific manuals.
• Ability to write advanced documents and correspondence.
• Ability to speak effectively before groups of customers or employees of the organization.
• Bilingual proficiency in French may be required depending on location.
• Ability to multi-task and maintain organization in a fast paced changing environment.
• Strong planning and organizational skills.
• Ability to work effectively and cooperatively in a team environment under significant time pressure.
• Demonstrated attention to detail and consistent ability to operate with accuracy and quality.

Work Authorization & Sponsorship

Applicants must be legally authorized to work in the United States. Altasciences is unable to provide sponsorship sponsorship transfers or visa maintenance for this position. All applicants must possess valid work authorization that does not require employer sponsorship now or in the future.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Benefits

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable.

Altasciences Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program

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