Cra Ii/senior, Sponsor-dedicated

4 weeks ago

Centurion, South Africa Labcorp Full time

**Labcorp Drug Development**

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

**Did you know?**

**We're looking to hire CRA II or Senior CRA for a sponsor-dedicated position.**

**Responsibilities**

You will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned:

- Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study;
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements;
- Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review;
- Monitor data for missing or implausible data;
- Ensure the resources of the Sponsor and Labcorp are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policy;
- Travel, including air travel, may be required and is an essential function of the job;
- Prepare accurate and timely trip reports;
- Responsible for all aspects of registry management as prescribed in the project plans;
- Undertake feasibility work when requested;
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor;
- Negotiate study budgets with potential investigators and assist the Labcorp legal department with statements of agreements as assigned;
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narrative and follow up of SAEs;
- Independently perform CRF review;
- query generation and resolution against established data review guidelines on Labcorp or client data management systems as assigned by management;
- Assist with training, of new employees, e.g. co-monitoring;
- Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned;
- Perform other duties as assigned by management.

**Requirements**:

- University or college degree in life sciences
- Minimum 3 years of independent monitoring experience
- Valid Driver's License
- Fluent English language skills (written & spoken)
- Have an understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
- Ability to work with mínimal supervision
- Good planning and organization skills
- Good computer skills with good working knowledge of a range of computer packages
- Advanced verbal and written communication skills
- Ability to resolve project-related problems and prioritizes workload for self and team
- Works efficiently and effectively in a matrix environment

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

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