Clinical Research Physician at Synexus Clinical Research Ltd

Are you looking to advance your career into the clinical trials space? Do you want to work for a leading multinational organisation, renown throughout the industry for its meteoric rise to success and dependability to deliver on global contracts across multiple therapeutic areas and phases? 

Are you looking to play an integral role in the future of medicine across the globe? If so, this may be the opportunity for you.

This is an excellent opportunity for an experienced research physician or GP with a keen interest in the clinical trials or the pharmaceutical industry to play a role in driving this organisation towards success.

As a Research Physician (RP) within Synexus you will be accountable for ensuring the commercial success of your site through the safe performance of your local clinical studies.

As an RP you will be the Principle Investigator (PI) or Sub Investigator for some or all of the studies at your site where you accept responsibility for all sponsor research studies while also ensuring ICH/GCP and local regulations are met.

This role will also see you take leadership through your guidance and training of colleagues while you work on studies at the Stanza Clinical Research Centre in Mamelodi, Pretoria.

Key Responsibilities

• Principle Investigator (PI) or Sub Investigator for some or all of the studies at your site ensuring ICH/GCP and local regulations are met
• Conducting clinical trials in line with the protocol and to ensure the recruitment of eligible participants onto study
• Providing information and support to consenting participants for a clinical study
• Reviewing screening, pre-screen and screen success rates for clinical trials
• Ensure all data queries are acted upon in a timely and efficient manner
• Sign off CRF, ICF
• Taking responsibility for ensuring serious adverse events / adverse events are reported appropriately
• SNC reporting
• Responsibility for taking ownership of being prepared for all GMC appraisals to ensure we see a positive outcome
• Liaising with and developing positive relations with sponsors, clients and clients’ contractors as required, projecting a helpful and courteous company image
• Carrying out clinical evaluation and clinical investigation of participants
• Constantly seeking and suggesting quality improvements
• Having responsibility for the medical wellbeing of participants during the clinical trial and referral to specialists or GP as required
• Fulfil the role of Principal Investigator/Sub-investigator, as per ICH GCP guidelines, in sponsor research studies at the Centre
• Ensure that new recruiting studies are enrolled according to plan within timelines and targets
• Ensure patient booking diary is filled according to capacity of the investigator time available – take appropriate action with Site/Operations Manager to fulfil this.
• Give Site Operations Manager feedback on patients’ suitability, review telephone screening and liaise with Operations Manager
• Develop recruitment strategy with Site Operations Manager and Recruitment Manager.
• Maintain awareness of screen fails and patient dropout rates, taking appropriate corrective action.
• Keep up to date with study status, ensuring each stage optimised.
• Establish and maintain relationships with local GPs (and specialists) and service providers.
• Fulfilling all appropriate medical duties as per the protocol
• Medical oversight for the conduct of the study at the site
• Providing training to all site study staff when needed
• Liaising with operations team and Project Managers
• Responsibility for pharmacovigilance activity at own site
• Participation in audits and review of audit findings

• Be a HPCSA registered doctor with previous experience within clinical research
• Have previous research experience and can demonstrate a strong interest in clinical research
• Have working knowledge of GCP (ICH-GCP and local regulations compliance)
• Follow study protocol’s and Standard Operating Procedures (SOP’s) at all times
• Act courteously and politely when dealing with patients, responding to any concerns or complaints in accordance to company SOP’s
• Provide practical help and guidance to all colleagues at site, providing practical solutions for any problems to support their development
• Demonstrate proactive behaviour to optimise the use of your time
• Exercise meticulous attention to detail in recording patient information and data ensuring any queries are acted upon in a timely and efficient manner
• Ensure all study documentation is completed, signed off and actions as appropriate
• Maintain a professional attitude and appearance at all times to colleagues and patients
• Proficiency in one or more African languages will be preferred.
• Take ownership for your own personal development by keeping abreast of medical literature
• Live the Synexus values