Principal Investigator
Vor 5 Tagen
Job Description
Overview:
We are seeking a qualified and experienced Principal Investigator (PI) to join our clinical research team. The ideal candidate will be a licensed physician with commercial clinical trial experience across multiple therapeutic indications and seeking or holding an Approbatin license. This is a key leadership role in the conduct of clinical trials at our clinet's site, ensuring participant safety and data integrity.
Key Responsibilities:
Serve as the Principal Investigator for industry-sponsored clinical trials across various therapeutic areas
Oversee the clinical and operational conduct of studies in compliance with the protocol, GCP, ICH guidelines, and all applicable regulatory requirements.
Supervise and medically evaluate study participants, assess adverse events, and provide clinical oversight of the study team.
Collaborate with sponsors, CROs, and internal staff to support site feasibility, study start-up, patient recruitment, and successful execution of clinical trials.
Ensure proper documentation of source data, electronic case report forms (eCRFs), and all essential trial documents.
Maintain accurate and up-to-date training and licensing records, including qualifications required for an Approbation license.
Participate in monitoring visits, audits, and inspections as needed.
Qualifications:
Medical degree (MD or equivalent) with active, unrestricted medical license.
Eligible for or currently holding an Approbation license
Minimum of 2 years of experience as a PI or Sub-Investigator in commercial (industry-sponsored) clinical trials.
Demonstrated experience working across multiple therapeutic indications.
- Has experiencebudget manamgement for the site and can think creatively to boost revenue for the site.
Strong knowledge of ICH-GCP and local/international regulatory requirements.
Excellent leadership, communication, and organizational skills.
Preferred Skills:
Experience with site initiation, patient recruitment strategies, and clinical operations.
Familiarity with electronic data capture (EDC) systems and regulatory document platforms.
Bilingual or multilingual abilities are a plus, especially in [insert relevant languages].
We Offer:
Competitive compensation
Supportive research team and infrastructure
Opportunities for professional development and training
Involvement in cutting-edge clinical research with top sponsors