Medical Research Physician
2 weeks ago
Simbec-Orion is a dynamic and innovative Contract Research Organization (CRO) with a strong focus on delivering tailored solutions to meet the unique needs of our clients. With a wide range of therapeutic expertise and a commitment to excellence, we strive to provide exceptional support to our clients in achieving their clinical and commercial objectives.
The RoleWe are seeking a highly skilled Research Physician to join our Medical - Clinical Pharmacology Department. As a key member of our team, you will be responsible for medically screening healthy volunteers participating in clinical trials at our Clinical Pharmacology Unit. Your expertise will also be utilized in providing ongoing medical support for all trials, including reviewing ECGs, vital signs, blood results, and adverse events.
As a Principal Investigator, you will be responsible for ensuring that all procedures are conducted in accordance with acceptable medical, scientific, and ethical standards. You will also be responsible for ensuring that all trials are conducted in accordance with protocols, standard operating procedures (SOPs), and regulatory requirements.
Key Responsibilities:
- Perform medical screening for potential participants to ensure they meet the medical requirements of the study.
- Perform ongoing monitoring and post-study clinical examinations, including reviewing ECGs, vital signs, blood results, and adverse events.
- Act as a Principal Investigator on assigned studies, ensuring that all procedures are conducted in accordance with acceptable medical, scientific, and ethical standards.
- Monitor, assess, and record any adverse events and decide on the medical management of clinically significant events in conjunction with the Sponsor, Principal Investigator, and/or Study Physician.
- Review study protocols and participant information sheets to ensure they meet regulatory and ICH-GCP requirements.
- Prepare Safety Data for reports and present at Safety Review meetings with the client.
- Prepare study-specific training and training slides and deliver training to wider Medical, Clinical, and Enrolment Services departments.
Requirements:
- Medical Degree.
- 2 years clinical experience post-Foundation (or equivalent) in approved training posts.
- Member of a suitable medical defence organisation (e.g. MDU or MPS).
- Previous experience working within a Clinical Research Environment.
- Excellent communication skills with the ability to adapt communication style to different audiences.
- Experience of managing participant safety (eligibility, ongoing review/assessment) and management of Medical Emergencies.
- Competent in MS Office Packages.
- Excellent time management skills and ability to effectively manage changes to priorities and deadlines.
Desirable:
- Valid Advanced Life Support (ALS) certificate from the Resuscitation Council (UK).
- Post-graduate Qualification in Clinical Pharmacology.
- Previous Clinical Trial and/CRO/ Bio-Tech /Pharma Experience.
- Experience and understanding of requirements for a Phase I MHRA Accredited Unit.
- Experience in business development activities, including feasibility and strategic advice for proposal development and bid-defence meetings.
- Experience with Clinical Trial Management Systems (CTMS).
- Experience in leading cross-functional project/clinical teams.
- Risk identification/management; Decision-making and problem-solving skills.
- Competent in using Data Capturing Systems.
Why Join Us?
Simbec-Orion is a growing company with a passion for innovation and a commitment to excellence. We offer a dynamic and supportive work environment, with opportunities for professional growth and development. If you are a motivated and experienced Research Physician looking for a new challenge, we encourage you to apply for this exciting opportunity.
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