ABOUT US

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.

THE JOB

We are looking for a Screening Physician to join our Medical-Clinical Pharmacology team in Merthyr Tydfil (Wales) where you will perform medical screening for all healthy volunteers who want to take part in Clinical Trials at Simbec Orion's Clinical Pharmacology Unit. You will ensure that all procedures performed meet acceptable Medical, Scientific and Ethical Standards and that all trials are run in accordance with protocols, standard operating procedures (SOPs), regulatory requirements and ICH-GCP.

KEY ACCOUNTABILITIES

• Fully explain each study and obtain written informed consent from potential trial participants.
• Perform medical screening for potential participants to ensure they meet the medical requirements of the study.
• Review and evaluate Vital Signs, ECGs , Spirometry, Holters and Laboratory test results etc. for all studies.
• Report any clinically significant abnormal results and/or changes from baseline and action taken to the designated Study Principal Investigator, Medical Director and/or Sponsors.
• Evaluate participant's eligibility for inclusion in a specific study according to the information contained in the Investigator Brochure, Protocol and Informed Consent Document.
• Ensure communication with volunteers' General Practitioners regarding their participation in a study, collaborative care and follow-up.
• 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 protocols and subject information as needed to ensure they meet regulatory and ICH-GCP requirements.
• Prepare study-specific training and training slides and deliver training to wider Medical, Clinical and Enrolment Services departments.
• Act as Sub-Investigator for designated studies ensuring adequate continuity of care of trial subjects throughout study.
• Be proficient in the procedures of Advanced Life Support (ALS) to be capable of dealing with acute medical emergencies.

SKILLS REQUIRED

Essential:

• Medical Degree
• GMC Registered with a License to Practice that complies with revalidation requirements
• Clinical Experience required:
  • If Qualified before 2005: 2 years post-registration experience
  • If Qualified after 2005: 2 years clinical experience post-Foundation (or equivalent) in approved training posts
• Member of a suitable medical defence organisation (e.g. MDU or MPS)
• Excellent communication skills with the ability to adapt communication style to different audiences
• Excellent time management skills and ability to effectively manage changes to priorities and deadlines
• Experience of managing participant safety (eligibility, ongoing review/assessment) and management of Medical Emergencies
• High level of attention to detail
• Competent in MS Office Packages
  

Desirable:

• Valid Advance Life Support (ALS) certificate from the Resuscitation Council (UK)
• Previous Clinical Trial and/or CRO/Bio-Tech /Pharma Experience
• Knowledge of a Clinical Trial Management System (CTMS)
• Experience with Electronic Document Capturing Systems

WHY YOU SHOULD JOIN US

Simbec-Orion is growing fast. To keep up with demand, we're looking for the best people, from all areas of clinical development, to join our team.

We're dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

With experts from all disciplines under the same roof, you'll work alongside some of the industry's best. So if you'd like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We're waiting to hear from you.

Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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