Senior Research Physician

1. Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases.
2. We are looking for a Research Physician to join our Medical - Clinical Pharmacology Department.
3. You will act as a Principal Investigator on assigned studies, ensuring that all procedures performed are to acceptable Medical, Scientific and Ethical Standards.

Req ID: R-01298

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 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.

Key Accountabilities:

• Ensure the safety and welfare of trial participants and the delivery of high-quality studies in the Clinical Pharmacology Unit, in accordance with Simbec-Orion's Quality Management System, ICH-GCP; MHRA Phase I accreditation requirements and The Independent Health Care (Wales) Regulations 2011 at all times.
• Assess and develop key trial documents and reports (including study protocols, Risk Management Plans, study-specific training and safety reports) and advise/present on project safety, feasibility, and operationalisation internally and with clients.
• Perform screening, ongoing monitoring and post-study clinical examinations (including review of ECGs, vital signs, Spirometry, Holter, Laboratory results and management and assessment of adverse events) and clinical procedures as appropriate to each study (cannulation, dosing procedures, nasogastric tubes, skin biopsy samples etc.); reporting any clinically significant abnormal results and/or changes from baseline and action taken to the designated Study Principal Investigator, Senior Medical Director and/or Sponsors.
• Evaluate participant's eligibility and obtain written informed consent for inclusion in a specific study according to the information in the Investigator Brochure, Protocol and Informed Consent Document.
• Supports effective communication with volunteers' General Practitioners regarding their participation in a study, collaborative care and follow-up.
• Act as a Principal Investigator (including First in Human) / Sub-Investigator for clinical trials to the highest standards, including actively participating in data review and taking responsibility for trial (including dose escalation) decisions, and liaison with hospital specialists, GPs, consultants and others to recruit suitable volunteers and patients for clinical trials.
• Be proficient in Advanced Life Support and capable of dealing with acute medical emergencies that may arise in the Clinic Pharmacy Unit. Provide medical cover outside of normal working hours as part of an On-Call Rota.
• Line Management of Research Physicians and provide leadership support and guidance to the Heads of Departments for the Clinic and Enrolment Services departments to fulfil their roles successfully; Deputise for the Senior Medical Director.
• Participate in Commercial Development activities (including Feasibility assessment and Budget reviews when required) and take an active role in providing feasibility and strategic advice for proposal development at key client meetings and Bid Defence Meetings; Represent Simbec-Orion at national and international meetings/conferences seminars and workshops.
• Collaborate and consult with others to develop and maintain strong working relationships with peers, senior leaders, and key stakeholders to ensure projects are delivered on schedule and within budget.

Skills Required:

Essential:

• 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.

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