Clinical Research Associate

The Clinical Research Associate will identify, select, initiate and close-out appropriate investigational sites for clinical studies. The successful candidate(s) will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.

Responsibilities of the Clinical Research Associate

Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures

Site management to ensure proper adherence to protocol, source data verification and assess CRF entries

Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists

Assist with study protocol design, development and / or review if required

Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required

Perform pre-study initiation, interim monitoring and close out visits as required

Carry out drug formulation administration procedures and documentation records

Ensure adequacy of drug shipment and drug accountability

Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required

Organise / attend investigator meetings as required

Provide support to the Project Manager / Country Manager with ad-hoc tasks as required

Essential Criteria

Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline

Clear understanding of the drug development process

Significant experience in performing a Clinical Research Associate role

Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company

Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials

Ability to contribute to the development of clinical trial related documents and materials

Ability to independently perform pre-study initiation, interim monitoring and close out visits as required

Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines

Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail

Fluency in English (both written and spoken)

Willingness and ability to travel

Willingness and ability to be Homebased in South Africa

Desirable Criteria

Experience across a wide range of clinical indications / therapeutic areas

Ability and experience to work with an electronic case report form (eCRF)

Membership of local professional bodies or international clinical groups

Ability to mentor, train, supervise and inspire confidence in newcomers to the industry

Company Information

Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world’s leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.