Clinical Research Physician 1 (FTC Internal Candidates Only)

We have a great secondment opportunity for a Clinical Research Physician to join our medical team in Manchester.

The secondment will be to cover maternity leave and last up to 12 months.

 The focus of this role is to fulfil the role of Sub-Investigator and Principal Investigator (where delegated) in early phase and late phase clinical research studies in compliance with the protocol and ICH/GCP. 

Essential 

• Full and current GMC registration
• 2 years post-graduation experience (mandatory)

Desirable 

• 2+ Years of UK clinical experience in any specialty
• Previous clinical research experience in SMO/CRO
• Pharmaceutical experience 0-2 years (desirable)
• MRCP /MRCGP (desirable)

RESPONSIBILITIES:  

Clinical activities: 

• Fulfil the role of Sub Investigator / Principal Investigator where delegated. 
• Provision of medical care and oversight of clinical trial participants. 
• Ensure trial related procedures are completed in accordance with ICH-GCP guidelines and in compliance with the protocol. 
• Review medical records of potential study participants. 
• Remain proactive in participants study visits, including taking informed consent, physical examinations and other clinical procedures. 
• Ensure that study documentation is completed, signed off, and actioned, as appropriate. 
• Maintain accurate source notes. 
• Review medical reports and lab results. 
• Assist clinical staff members in various clinical activities as required. 
• Participate in site monitoring visits with Clinical Research Associates. 
• Ensure timelines for data queries are achieved. 
• Continuously work towards maintaining and improving quality in all areas. 
• On-call rota duties as required. 
• Assess and review memory clinic patients (only applicable to sites where MAC operates a memory clinic) 
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Management: 

• Attend Investigator Meetings (IM), Site Initiation Visits (SIV) and Pre-Study Selection Visits (PSSV) as required. 
• Review source documents. 
• Participate in sponsor and regulatory audits as required. 
• Participate in meetings with colleagues and customers. 

Leadership 

• Provide practical help and guidance to other staff. 
• Instil confidence in patients, customers and colleagues. 
• Providing training to the clinical/ recruitment teams on essential medical information and protocols when required. 

Commercial Awareness and Contribution to Targets 

• Maintain an awareness of our key customers and market competitors. 
• Share ideas from previous work environments to enhance current role. 
• Maintain an awareness of site KPI’s and contribute positively to meeting these targets. 

Professional development 

• Always maintain a professional attitude and appearance to customers/colleagues. 
• Ensure that GMC requirements for revalidation are met appropriately to retain license to practice. 
• Identify opportunities for self-development. 

Recruitment: 

• Assist with the development of recruitment strategy with the Envision team as a therapy area specialist. 
• Maintain awareness of chat and screen fails and patient drop-out rates, taking appropriate corrective action. 
• Keep up to date with study status, ensuring each stage is optimised. 
• Establish and maintain relationships with local GPs, Consultants and service providers. 

General: 

• Share experience and knowledge with colleagues as appropriate and in an appropriate manner. 
• Compliance with MAC policy on equality and diversity 
• To maintain professional qualifications required for the role, including continuous personal development 
• To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice 
• To work according to MAC SOPs, guidelines and policies 
• To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business-related data. 
• To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out 
• To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers 

PHYSICAL, WORK ENVIRONMENT, TRAVEL DEMANDS: 

• Dealing with bodily fluids. 
• Long periods looking at a computer screen. 
• Meeting deadlines and working within strict timelines. 
• Ability to travel between sites if required. 
• Ability to travel to national/international meetings. 

Please email [email protected] should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.