Study Coordinator I
Altasciences · Columbia
About The Role
The Study Coordinator I supports and coordinates the planning, execution, and reporting of nonclinical studies under the guidance of Study Director(s). This role is responsible for study administration, scheduling, documentation, compliance monitoring, and cross-functional coordination to ensure studies are conducted in accordance with protocols, standard operating procedures (SOPs), and regulatory guidelines.
What You'll Do Here
- Assist with the preparation, review, and/or distribution of study protocols, and amendments; with experience, may independently draft study documentation.
- Coordinate and/or participate in 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. Identify discrepancies, coordinate resolution of data issues, and escalate deviations to Study Director(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 or assist in monitoring in-life study activities as appropriate. 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.
- Maintain accurate, organized, and audit-ready study documentation, including study files, schedules, and correspondence.
- May support archiving and preparation of studies for finalization.
- Assist with 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 You'll Need to Succeed
- A Bachelor’s 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
#LI-JR1