Study Coordinator I

Posted Yesterday
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18447, Olyphant, PA, USA
In-Office
Junior
Information Technology • Analytics • Biotech
The Role
Provide administrative and professional support to Study Directors and PIs for GLP and non-GLP studies: prepare and manage protocols and study materials, schedule data collection, review raw data for errors and GLP compliance, coordinate audits and client visits, perform data verification, generate data tables, assist report drafting and archiving, and track study milestones.
Summary Generated by Built In

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role
Works under the guidance of designated Study Director(s), Contributing Scientists and Principal Investigators, as appropriate, to provide administrative and professional support for accurate study progression based on Protocols and Method Validation Plans, organization, scheduling, reporting, client relations and operations.
What You'll Do Here  

  • Assist with the preparation and distribution of Protocols, Analytical Study Plans and Amendments/Amended Protocols.

  • Schedule and/or help conduct Protocol review meetings with Study Director guidance.

  • Create study schedules for data collection within the electronic data capture system and implement schedule changes as a result of Protocol Amendments/Amended Protocols, as necessary.

  • Draft and edit Project Review Forms (PRF) with Study Director guidance.

  • Assist with preparation and maintenance of study notebooks, study forms, and other necessary materials for studies.

  • Support the Study Director or Principal Investigator with the planning and hosting of client visits.

  • Review raw data throughout the life of a study for clerical/technical errors, thoroughness and consistency, and adherence to SOPs, Protocol specifications and compliance with Good Laboratory Practices (GLPs), as appropriate.

  • Coordinate correction of raw data with appropriate staff.

  • Report any deviations to the Study Director.

  • Coordinate study activities related to audits.

  • Perform data verification as needed.

  • Generate data tables for inclusion in reports based on requirements

  • Assist in the preparation of the report(s) (e.g. drafting the Materials and Methods section), utilizing the appropriate report template.

  • Collect and collate report components for the final report under the supervision of the

  • Study Director utilizing electronic publishing tools.

  • Provide assistance with archiving and preparation of studies for finalization.

  • Support the Study Director(s), Contributing Scientists and Principal Investigators with the monitoring, tracking and communication of study milestones throughout departments.

  • Provide coordination for both non-GLP studies and GLP studies from study initiation to finalization under the guidance of the Study Director.

What You'll Need to Succeed  

  • A Bachelor degree or college coursework in a scientific discipline and relevant experience may substitute for the educational requirement.

  • Mimimum of 1 year experience in a scientific environment or an equivalent combination of education and experience. 

  • General to advanced computer skills: proficiency working with MS Word, Excel and Adobe Acrobat.

  • Excellent verbal and written communication skills

  • Working knowledge of descriptive statistics.

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.
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

#LI-TN1

MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!

Skills Required

  • Bachelor degree or college coursework in a scientific discipline (or equivalent experience)
  • Minimum of 1 year experience in a scientific environment or equivalent combination of education and experience
  • Proficiency with MS Word, Excel and Adobe Acrobat
  • General to advanced computer skills and familiarity with electronic data capture systems and electronic publishing tools
  • Excellent verbal and written communication skills
  • Working knowledge of descriptive statistics
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The Company
HQ: Laval, Quebec
1,832 Employees
Year Founded: 1995

What We Do

Outsourcing made easy with a one-stop solution to early-phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!

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