Study Coordinator I
Scranton, PA - USA
Job Summary
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 youre a recent college graduate or seeking your next career opportunity its 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 Youll 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 Youll 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!
Required Experience:
IC
About Company
Contract research organization specialized in seamless, end-to-end, early phase drug development, we act to get your most promising compounds into and through early phase clinical trials.