- Reviews protocols for scientific, logistical and safety feasibility, as requested.
- Adheres to client directives and study protocols for assigned projects.
- Performs role as described in FDA Form 1572, including, but not limited to informed consent and screening examinations of subjects, clinical management of safety issues for the individual subjects as well as the study cohort.
- Presents all first-in-human and other high risk trials to the Human Safety Committee (HSC) to ensure those trials are thoroughly reviewed and approved by the voting members. Develops a risk management plan (RMP) with the Project Manager to mitigate any risk to subject safety for all studies.
- Provides training on assigned studies, as requested.
- Discusses medical concerns with investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, as appropriate, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
- Provides medical consultation to team members and answers study related medical questions. Communicates with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. Deviates from current approved study protocol only if it is in the medical emergent safety needs of a study participant.
- Monitors, evaluates and takes action as needed on safety variables (adverse events, laboratory/ECG abnormalities, changes in patient medical status, and unblinding requests) during a clinical trial.
- Assesses reported adverse events and determines causality and study drug relationship. Assesses and determines the clinical significance of out of range laboratory values and other observed abnormalities noted within safety assessments.
- Contributes to departmental process improvement initiatives.
- Available for weekend call coverage (rotated through investigator team)
- A valid medical degree (M.D. or D.O.)
- A medical license in good standing, with unrestricted ability to practice in place of work, where Applicable. Nevada State licensure will be required.
- Board Certification in respective field preferred.
- A valid ICH GCP certificate (this can be acquired upon employment)
- No previous experience in clinical research is required but is preferred.
- Must have general medical practitioner diagnosis and treatment proficiency.
- Knowledge of important regulatory considerations and experience with national and/or international regulatory authorities
- Ability to assess the safety and tolerability of different classes of drugs
- Overall knowledge of the drug development process and familiarity with guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
- Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve
- Advanced analytical ability
- Ability to exercise discretion and sound judgement
- Strong decision-making, negotiation and influencing skills
- Excellent communication skills and English fluency
- Excellent organizational skills and detail-orientated leadership approach
- Proficiency in basic computer applications
- Ability to work in a team environment
- Work is performed in an office environment with exposure to electrical office equipment.
- Working hours: Monday-Friday approximately 7am-3pm local time. Light rotational weekend hours are required(approximately every 3rd or 4th weekend). Recruiter can provide more specifics.
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Associate Medical Director/Investigator - Las Vegas, United States - Thermo Fisher Scientific
Description
Job DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Due to continued growth, we are looking to appoint an Associate Medical Director at the Las Vegas Clinical Research Unit. This role is an office-based position for a motivated Physician. The Associate Medical Director serves as the physician investigator on all assigned clinical trials providing medical oversight for a particular protocol and client. Ensures that the protocol is being conducted under all applicable laws, regulations and per ICH-GCP guidelines in the organization's Clinical Research Unit (CRU). Consults with clients and provides scientific and medical insight for protocols. Researches compounds being considered by the CRU for subject safety. Evaluates and signs off on medical data collected, completed case report forms (CRFs) and final clinical study reports (CSRs). Fosters relationships with clients and supports operational and business development staff. Supports local team in all quality initiatives and regulatory requirements at a busy Phase 1 32 bed facility understanding that participants often domiciled for extended duration.
Essential Functions:
