- 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.
- 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
- 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
-
Physician Associate
1 day ago
Sheffield Health & Social Care NHS Foundation Trust Sheffield, United KingdomSheffield Health and Social Care are recruiting two keen Physician Associates, for posts in the following areas: · - Forensic · - Inpatient · These roles provides an opportunity for an enthusiastic Physician Associates to play a key role in the management of patients and to suppo ...
-
Physician Associate
3 days ago
Sheffield Health & Social Care NHS Foundation Trust Sheffield, United KingdomSheffield Health and Social Care are excited to be able to offer a Physician Associate post in G1, Grenoside Grange. · South Yorkshire Mental Health Trusts are seeking enthusiastic Physician Associates to play key roles in the management of patients and to support the effective f ...
-
Physicians Associate
5 days ago
Sheffield Teaching Hospitals NHS Foundation Trust Sheffield, United KingdomAs part of the pioneering Physician Associates programme at Sheffield Teaching Hospitals NHS Foundation Trust, Haematology are recruiting a Physicians Associate to work on our inpatient wards, Haematology Day ward, and with colleagues in our Outpatient clinics, based at the Royal ...
-
Mental Health Practitioner
3 days ago
Sheffield Teaching Hospitals NHS Foundation Trust Sheffield, United KingdomSheffield Occupational Health Service provides a high quality occupational health service to NHS Trusts, Universities and a number of private sector clients mostly within the Sheffield area. · We are looking to recruit a OH Mental Health Practitioner, with experience of working w ...
-
Consultant in Psychiatry
2 days ago
Sheffield Health & Social Care NHS Foundation Trust Sheffield, United KingdomWe are seeking a motivated and committed Consultant to join our team on Stanage Ward. · The inpatient unit (Stanage Ward) has 16 male beds and a full multidisciplinary team (medical, nursing, occupational therapy, physician associate, pharmacy, psychology, housekeeping, administr ...
-
Associate Medical Director for Medical Education
13 hours ago
GatenbySanderson Sheffield, United KingdomEmployer: · - Sheffield Teaching Hospitals NHS Foundation Trust- Location: · - Sheffield- Salary: · - Attractive Salary- Closing date: · - 9am Friday 15th September 2023- Job Ref: · - GSe101535**Recruitment timetable**: · - Closing Date- 9am Friday 15th September 2023- Preliminar ...
-
Senior / Clinical Research Physician
1 day ago
Pharmiweb Leeds, United KingdomSimbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operation ...
-
Assistant Professor in Medicine
1 day ago
University of Bradford Bradford, United Kingdom**Faculty of Life Sciences**: · **School of Pharmacy and Medical Sciences**: · **Salary**: · - £44,737 to £51,805 per annum pro rata- 0.4 FTE**Post Type**: · - Part Time**Contract Type**: · - Permanent**Closing Date**: · - Friday 24 February 2023**Interview Date**: · - To be conf ...
-
Fortrea Leeds, United KingdomAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...
-
Physician Associate
4 days ago
Medical Staffing Leeds, United Kingdom**Role Title: Physician Associate** · Medical Staffing is delighted to offer a great opportunity for a highly motivated and experienced Physician Associate who wishes to develop their career within an exceptional primary care environment. · **A bit about the role**: · - Provide f ...
-
Physician Associate
13 hours ago
Leeds Teaching Hospitals Leeds, United KingdomJOB PURPOSE This is an innovative role to give newly qualified or more experienced Physician Associates a one year rotation through two hospital-based Medical and/or Surgical specialties. The PAs will spend six months rotating through two departments. The details for the rotation ...
-
Observational Research Executive
3 days ago
Omnicom Health Group Bollington, United KingdomOverview: · **Observational Research Executive** · **Start Date: Sept -Oct 2023** · Randomized control trials (RCTs) are the established way for evaluation of the safety and efficacy of pharmaceuticals. Such studies are highly controlled and are typically conducted with a small a ...
-
Talent Community: Field Clinical Specialist
6 days ago
Boston Scientific Corporation Leeds, United Kingdom**Talent Community: Field Clinical Specialist, Electrophysiology (Farapulse)**: · - Work mode: Field Based- Onsite Location(s): Leeds, United KingdomTalent Community: Field Clinical Specialist, Electrophysiology (Farapulse) · **Please note - **The purpose of this job posting is t ...
-
Deputy Head of Service
1 week ago
Northern Care Alliance NHS Group Oldham, United KingdomThe Northern Care Alliance NHS Foundation Trust (NCA) brings together staff and services from the former Salford Royal NHS Foundation Trust and The Pennine Acute Hospitals NHS Trust. The sheer size, scale and potential of our combined service is huge. Together, we've a wealth of ...
-
Senior Assistant Technical Officer
1 week ago
Leeds Teaching Hospitals Leeds, United KingdomPrincipal Duties & Areas of Responsibility Clinical Duties Carries out all aspects of clinical and administration work as approved by their line manager, working within established codes of practice and local departmental standard operating procedures. To be professionally and le ...
-
Consultant - Endocrinology and Diabetes
1 week ago
Stockport NHS Foundation Trust Stockport, United KingdomThis post is based the department of Diabetes and Endocrinology supporting the work of the Directorate in delivering inpatient services and participating in speciality outpatient clinics in Diabetes and Endocrinology. The post provides training and experience in specialty diabete ...
-
Senior Assistant Technical Officer
3 days ago
Leeds Teaching Hospitals Leeds, United KingdomPrincipal Duties & Areas of Responsibility Clinical Duties Carries out all aspects of clinical work as approved by their Line Manager, working within established codes of practice. Performs the following investigations on a range of Cardiac and Medical patients, including the eld ...
-
Nepsec Training Programme Facilitator
1 week ago
Sheffield Teaching Hospitals NHS Foundation Trust Wakefield, United KingdomThe North of England Pathology & Screening Education Centre is looking for an experienced healthcare professional to design, manage and contribute to the training of the cervical sample taker training programme of learning. · There will also be some requirement to manage the duti ...
-
Business Intelligence Lead
1 week ago
Johnson & Johnson Leeds, United KingdomFor more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.- We know that the success of o ...
-
Associate Editor
2 days ago
Omnicom Health Group Bollington, United KingdomOverview: · **VACANCY** · **Associate Editor** · **Adelphi Real World (ARW)** · Randomized control trials (RCTs) are the established way of evaluating the safety and efficacy of pharmaceuticals. Such studies are highly controlled and typically conducted with a small and very spec ...
Senior Research Physician - Sheffield, United Kingdom - Pharmiweb
Description
ABOUT USSimbec-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
SKILLS REQUIRED
ESSENTIAL
DESIRABLE
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.