Principal Investigator

About the role

The PI at Celerion is responsible for ensuring the safety of participants in clinical trials and overseeing the execution of studies according to approved protocols and regulatory guidelines.

Responsibilities

• Review protocol and Investigator Brochure for subject safety, scientific, and operational feasibility of study.
• Complete FDA 1572 and financial disclosure forms.
• Attend study initiation meetings with sponsor.
• Communicate with Institutional Review Board during protocol approval process and subject safety issues.
• Explain study to subject and answer questions, ensure proper consent, and perform screening examination.
• Final review of all screening data and authorization of subjects to be enrolled in the study.
• Perform scheduled and unscheduled per protocol physicals during study conduct.
• Manage adverse events/clinical evaluation of subjects and determine adverse event relationship to investigational product, severity, and etiology.
• Review pre-dose lab work, ECGs, and other study data and determine appropriate action plan based on these results.
• Compose SAE and other reporting documents as indicated.
• Review and sign Case Report Forms and final Clinical Study Reports.
• Review all serious adverse events and SUSARs to the Sponsor and IRB within statutory timelines.
• Data review of all end-of-study data to determine if re-checks are necessary.
• Safety-monitoring - perform end-of-study physical exams and follow-up ongoing adverse events.
• Case Report Forms review - review and sign all case report forms at end of study.
• Aid in identifying and maintaining a network of physician specialists to contract on studies.
• Present Celerion’s capabilities and experience during sponsor meetings and events.
• Assist in the design of study and time/event schedules involving special medical procedures.
• Function as a medical/clinical informational resource for the site.
• Aid other departments with development of SOPs, training plans, etc.
• Facilitate emergency response training and review of clinical safety procedures.

Qualifications

• MD or DO degree and current state license.
• Basic Life Support and Advanced Cardiac Life Support certification.
• Successful completion of an ACGME residency program in family medicine, internal medicine, or emergency medicine.
• Hold a DEA certificate for schedule II medications.
• 3-5 years of medical/clinical experience preferred.
• Clinical research experience preferred.

Skills

• Strong communication skills.
• Ability to manage multiple tasks and meet deadlines.
• Proficiency in medical terminology and regulatory compliance.
• Knowledge of clinical trial processes and procedures.

Benefits

• Flexible scheduling options.
• Competitive compensation package.
• Professional development opportunities.
• Health insurance benefits.
• Employee assistance programs.

Pay

Salary range: $XX,XXX - $XXXXX, depending on experience and qualifications.

Schedule

Flexible hours to accommodate clinical trial needs.

Company Culture

Celerion values integrity, trust, teamwork, and respect. We are committed to providing a supportive and inclusive environment for all employees.

Equal Opportunity Employer

Celerion is an equal opportunity employer and does not discriminate against any applicant or employee on the basis of race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.