Medical Research Physician

2 weeks ago

Merthyr Tydfil, Merthyr Tydfil, United Kingdom Simbec-Orion Full time
About Us

Simbec-Orion is a dynamic and agile full-service Contract Research Organization (CRO) with a strong presence in clinical pharmacology, oncology, and rare diseases. Our team is dedicated to delivering tailored and scalable solutions that meet the unique needs of each project, ensuring our clients achieve their clinical and commercial objectives.

The Role

We 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, providing ongoing medical support, and acting as a Principal Investigator on assigned studies. Your primary focus will be on ensuring that all procedures are conducted in accordance with medical, scientific, and ethical standards, and that trials meet all regulatory requirements and ICH-GCP.

Key Responsibilities
  • Perform medical screening for potential participants to ensure they meet the medical requirements of the study.
  • Conduct ongoing monitoring and post-study clinical examinations, reviewing ECGs, vital signs, blood results, and adverse events, and performing clinical procedures as necessary.
  • Report any clinically significant abnormal results and/or changes from baseline and take appropriate action.
  • Evaluate participant eligibility for inclusion in a specific study based on the information contained in the Investigator Brochure, Protocol, and Informed Consent Document.
  • 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 deliver training to wider Medical, Clinical, and Enrolment Services departments.
  • Be proficient in Advanced Life Support procedures and capable of dealing with acute medical emergencies that may arise in the Clinic Pharmacology Unit.
  • Provide medical cover outside of normal working hours as part of an On-Call Rota.
Requirements
  • Medical Degree with 2 years of 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/or 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 rapidly growing company that offers exposure to innovative new drugs in patient populations with serious unmet medical needs. Our team is passionate about delivering high-quality services that make a real difference in people's lives. 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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