Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
- 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.
- Always ensure subject safety; 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 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.
- Particiapte in sponsor visits and regulatory audits.
- Review study protocols and SOP's.
- 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
- Hold a MD degree from an accredited Physician Program
- Current Advanced Cardiac Life Support (ACLS) certification (as required by location).
- Current Basic Life Support (BLS, CPR/AED) certification (as required by location).
- Excellent communication skills.
- Previous experience with similar responsibilities; ideally related to the Clinical Research industry.
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
- Training & Development Programs
- Employee Referral Bonus
- Job Family Doctor
- Pay Type Salary
- Kansas, USA