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, well 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 ROLE
We are looking for a Research Physician to join our Medical - Clinical Pharmacology Department where you will medically screen all healthy volunteers who want to participate in Clinical Trials at Simbec-Orion's Clinical Pharmacology Unit and provide ongoing medical support for all trials undertaken by Simbec-Orion by reviewing ECGs, vital signs, blood results and adverse events. In addition, you will act as a Principal Investigator on assigned studies, ensuring that all procedures performed are to acceptable Medical, Scientific and Ethical Standards and, that all trials are run according to protocols standard operating procedures (SOPs), and that they meet all regulatory requirements and ICH-GCP.
Job description: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.
- Perform ongoing monitoring and post-study clinical examinations (review of ECGs, vital signs, blood results and adverse events) and clinical procedures as appropriate to each study (cannulation, dosing procedures, nasogastric tubes, skin biopsy samples etc.).
- Review and evaluate Vital Signs, ECGs, Spirometry, Holter 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 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.
- Act as Sub-Investigator/Study Physician for designated studies ensuring adequate continuity of care of trial participants throughout studies.
- Be proficient in the procedures of Advance Life Support and to be 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.
SKILLS REQUIRED
ESSENTIAL
- Medical Degree.
- GMC Registered with a License to Practice and comply 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)
- 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
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