Clinical Research Associate Specialist
Há 2 dias
The In-House Clinical Research Associate (IHCRA) is a vital member of a clinical project team responsible for the execution and delivery of clinical research projects.
Key Responsibilities include:
- Providing exceptional customer service to project teams and investigative sites, conducting site contacts, and documenting contacts as required per study guidelines.
- Maintaining site performance and implementing action plans for underperforming sites.
- Supporting CRAs with preparation for site visits, performing case report form reviews, query generation and resolution.
- Coordinating study visits, managing shipment of drug, ancillary supplies, and laboratory kits/samples.
On-site Tasks:
- Assisting Clinical Research Associates in completing on-site tasks as necessary.
Remote Tasks:
- Performing remote visits, facilitating translation and back-translation of necessary documents, undertaking administrative tasks.
Qualifications:
- Bachelor's degree or higher from an accredited institution in a related allied health field or relevant certification.
- In lieu of the above requirement, candidates with 2-3 or more years of relevant clinical research experience may be considered.
Experience:
- Minimum one year of experience in a related field.
- Able to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP.
- Excellent organizational and time management skills, strong communication skills (oral and written).
Physical Demands/Work Environment:
- General office environment, some travel required.
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