Clinical Research Physician Investigator - Part Time
Thermo Fisher
Summary
Conducts all clinical trials (studies) according to ICH GCP, local regulations, study protocol and company processes. Ensures the medical wellbeing and safety of the participants through the safe performance and execution of the studies. Drives clinical oversight and quality of the studies at the site, or with PI oversight at other sites. Works as part of a team, with focus on positive interactions with sponsors, clients and staff members at the site. Participates and engages in driving delivery of study targets, thereby contributing to the commercial success of the site which includes: recruitment, enrolment and retention of study participants. Focuses on own development of skills and expertise and assists with training, mentoring and general support to junior physicians. Generally takes on a more active role giving input into the site processes and sharing best practices gained from years of experience. Manages and oversees various studies simultaneously with the responsibility of PI and sub-I.
Job description
Primary Responsibilities
- Carries out clinical evaluation and assessment of participants to ensure eligible participants are recruited and monitored for safety and adherence.
- Attends Site Initiation Visits (SIV), Pre-Selections Visits (PSV) and Investigators meetings as required.
- Participates in recruitment initiatives and strategy development to ensure targets are achieved; ensuring recruiting studies enroll according to plan within timelines and targets.
- Reviews enrollment progress, pre-screening and screening success rates, screen failure rates, safety and retention of participants.
- Interprets protocols and IB.
- Manages and reviews IVRS, CRF/EDC, if applicable.
- Oversees management of investigational medical product (IMP).
- Identifies and reports trends within studies to manage it in light of conduct and outcome.
- Oversees multiple studies and/or studies with higher numbers.
- Cares for and protects the safety of participants through ethical conduct, this should receive the highest priority at all times during all aspects of the study.
- Fulfills and complies with all medical duties, ensuring that clinical trials are performed to acceptable medical, scientific and ethical standards and meet the requirements as per protocol, SOP/COP ICH and local GCP guidelines and regulations.
Education and Experience
- A valid medical degree within the country of practice with at least 3 years working as a licensed physician, as well as other medical licenses as may be required within the country (e.g. dispensing license).
- Valid registration as a medical practitioner, with a medical license in good standing and with unrestricted ability to practice in place of work, where applicable.
- Prior clinical research experience is preferred but not required. Candidates should possess sufficient clinical expertise and medical judgment to safely conduct protocol-driven clinical research and oversee study participants. Strong clinical backgrounds seeking to transition into clinical research are encouraged to apply.
- A valid ICH GCP certificate (can be obtained after employment).
- Exceptional general medical practitioner diagnosis and treatment proficiency.
Knowledge, Skills, and Abilities
- Exceptional understanding of medical terminology, drug safety, and interpretation of lab reports.
- Thorough understanding of scientific concepts related to the design and analysis of clinical trials.
- Excellent written, verbal and presentation skills.
- Capable of working well under pressure.
- Capable of effectively prioritizing and managing multiple projects.
- Strong planning, organizational and project management skills.
- Capable of managing outside agencies in order to fulfill project objectives.
- Self-starter with ability to thrive under pressure in a fast paced environment.
- Skilled in Word, Excel, and PowerPoint and proficient with the Internet.
- Displays strategic leadership by influencing the site team to deliver on targets.
Requirements
- Valid medical degree within the country of practice
- At least 3 years working as a licensed physician
- Valid registration as a medical practitioner with a medical license in good standing and unrestricted ability to practice
- Valid ICH GCP certificate (can be obtained after employment)
- Exceptional general medical practitioner diagnosis and treatment proficiency
- Exceptional understanding of medical terminology, drug safety, and interpretation of lab reports
- Thorough understanding of scientific concepts related to the design and analysis of clinical trials
- Excellent written, verbal and presentation skills
- Capable of working well under pressure
- Capable of effectively prioritizing and managing multiple projects
- Strong planning, organizational and project management skills
- Capable of managing outside agencies in order to fulfill project objectives
- Self-starter with ability to thrive under pressure in a fast paced environment
- Skilled in Word, Excel, and PowerPoint and proficient with the Internet
- Displays strategic leadership by influencing the site team to deliver on targets
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check including drug screening
Company overview
Thermo Fisher Scientific is a global leader in serving science, with annual revenue of approximately $40 billion. The company provides a comprehensive portfolio of analytical instruments, equipment, reagents and consumables, software, and services for research, analysis, discovery, and diagnostics. Their mission is to enable customers to make the world healthier, cleaner, and safer by accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, and increasing laboratory productivity. Thermo Fisher serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies worldwide. The company operates through four business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services.