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 The Principal Investigator is responsible for the supervision and delegation of the tasks related to the clinical trial they are Principal Investigator of. The Principal Investigator will promote Good Clinical Practices (GCP) during the conduct of clinical investigations by ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of data generated at the site and directing the conduct of the clinical investigation according to regulation/guidance and standard operating procedure (SOP).
You'll Do Here Supervise the clinical activities for the clinical trial they are Principal Investigator. Delegation of trial related tasks and the review of employees on the Delegation of Authority and Signature Log per job title/training record.
Perform protocol training. Provide documentation for the Sub-Investigators.
Ensure subject safety at all times, this may include but is not limited to: review of clinical laboratory results and/or other test results. Review and/or performance of vital signs, ECGs or other safety tests.
Perform critical trial related tasks and/or make trial related decisions during the course of the trial. Ensure subject eligibility is met based on protocol inclusionary/exclusionary criteria and that the subject continues to meet eligibility criteria throughout the course of a clinical trial.
Ensure requirements related to obtaining informed consent are met. Perform physical examinations and medical history intake and review.
Be on-site for surveillance as required by protocol and remain available on-call for medical events. Record and follow-up on adverse events and determine causality.
Report serious adverse events to appropriate parties. Participate in sponsor visits and regulatory audits.
Document study related events incompliance with GCP. Review study protocols and SOPs.
Complete and/or review regulatory documents as applicable. Participate in sponsor visits and regulatory audits.
May act as Sub-Investigator on studies not assigned to them as Principal Investigator. What You'll Need to Succeed MD degree from an accredited Physician Program and Advanced Cardiac Life Support (ACLS) certification required.
Previous experience with similar responsibilities; ideally related to the industry. 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 Altasciences’ Incentive Programs Include: Training & Development Programs Employee Referral Bonus Program #LI-AN1 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.
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