Senior Medical Researcher

4 weeks ago

Glasgow, Glasgow City, United Kingdom Pharmiweb Full time
About Us

Simbec-Orion is a full-service Contract Research Organization (CRO) with extensive experience in clinical pharmacology, oncology, and rare diseases. Our team of experts provides tailored clinical development solutions for small and mid-size drug developers.

We prioritize scalability and adaptability, ensuring our delivery style, communications, and operations meet the unique needs of each project. Our goal is to improve patients' lives by bringing innovative treatments to market.

The Role

We are seeking a 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. You will also provide ongoing medical support, reviewing ECGs, vital signs, blood results, and adverse events. Additionally, you will act as a Principal Investigator on assigned studies, ensuring all procedures meet medical, scientific, and ethical standards.

Key Accountabilities
  • Explain each study to potential participants and obtain written informed consent.
  • Perform medical screening to ensure participants meet study requirements.
  • Conduct ongoing monitoring and post-study clinical examinations, reviewing ECGs, vital signs, blood results, and adverse events.
  • Review and evaluate vital signs, ECGs, spirometry, holter, and laboratory test results.
  • Report clinically significant abnormal results and take necessary actions.
  • Evaluate participant eligibility based on the Investigator Brochure, Protocol, and Informed Consent Document.
  • Communicate with participants' general practitioners regarding their participation and follow-up care.
  • Monitor, assess, and record adverse events, deciding on medical management with the Sponsor, Principal Investigator, and Study Physician.
  • Review study protocols and participant information sheets to ensure regulatory and ICH-GCP compliance.
  • Prepare safety data for reports and present at Safety Review meetings with clients.
  • Prepare study-specific training and deliver training to Medical, Clinical, and Enrolment Services departments.
  • Act as Sub-Investigator/Study Physician for designated studies, ensuring continuity of care for trial participants.
  • Be proficient in Advance Life Support and capable of dealing with acute medical emergencies.
  • Provide medical cover outside of normal working hours as part of an On-Call Rota.

Skills Required

  • Medical Degree.
  • GMC Registered with a License to Practice and comply with revalidation requirements.
  • Clinical Experience: 2 years post-registration experience (if qualified before 2005) or 2 years clinical experience post-Foundation (or equivalent) in approved training posts (if qualified after 2005).
  • 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 and 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 You Should Join Us

Simbec-Orion is a growing company with a strong focus on innovation and patient care. We offer a dynamic and supportive work environment, with opportunities for professional growth and development. If you are passionate about clinical research and development, and want to be part of a team that is making a difference in patients' lives, we encourage you to apply for this exciting opportunity.

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