About Us
We are driven by our passion to improve patients' lives, and we strive to make a positive impact through the application of our skills, experience, and knowledge to advance medicine.
Our mission is to deliver flexible, innovative, and high-quality solutions for our clients with integrity.
The Role
We are seeking a Research Physician to join our Medical-Clinical Pharmacology Department. As a Research Physician, you will be responsible for medically screening all healthy volunteers who wish to participate in Clinical Trials at Simbec-Orion's Clinical Pharmacology Unit and providing ongoing medical support for all trials undertaken by Simbec-Orion.
You will also act as a Principal Investigator on assigned studies, ensuring that all procedures performed meet acceptable Medical, Scientific, and Ethical Standards, and that all trials are run according to protocols, standard operating procedures (SOPs), and regulatory requirements, including 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.
* Perform ongoing monitoring and post-study clinical examinations, including reviewing ECGs, vital signs, blood results, and adverse events.
* 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 actions taken to the designated Study Principal Investigator, Medical Director, and/or Sponsors.
* Evaluate participant 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 Advance 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.
Skills Required
Essential
* Medical Degree.
* GMC Registered with a License to Practice and comply with revalidation requirements.
* Clinical Experience required:
o If Qualified before 2005: 2 years post-registration experience.
o 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.
Why You Should Join Us
Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials.
We are perfectly structured to 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 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.