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Senior Research Physician

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Merthyr Tydfil, Merthyr Tydfil, United Kingdom SoftwareOne India Pvt. Ltd. Full time
Job Title: Senior Research Physician

Job Summary:

We are seeking a highly skilled Senior Research Physician to join our Medical - Clinical Pharmacology Department. As a Senior Research Physician, you will be responsible for medically screening all healthy volunteers who want to participate in Clinical Trials at our Clinical Pharmacology Unit and providing ongoing medical support for all trials undertaken by our company.

Key Responsibilities:

• 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.

Requirements:

• 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

What We Offer:

• 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