Clinical Research Associate (CRAs) are responsible for coordinating and overseeing the execution of studies and clinical trials. They have a hand in everything from recruiting study participants to creating study documentation, collecting patient data, and performing quality assurance audits to ensure study protocols are being followed.
Requirements
- BSc/BA in Computer Science, Engineering or relevant field; graduate degree in Data Science or other quantitative field is preferred
Responsibilities
- Assisting in the preparation of Trial Master Files (TMFs), Investigator Trial Files (ITFs) and Pharmacy Files (PF).
- Reviewing draft protocols and protocol amendments, case report forms (CRFs), informed consent documents (ICDs), research ethics committee application using the most current system.
- Assisting with site selection, assessment and documentation of potential investigational sites through feasibility questionnaires and conducting pre-study visits.
- Organizing, conducting and documenting site initiation visits.
- Providing training and support to site staff, new SRAs or other personnel.
- Ensuring sites comply with the clinical trial protocol, policies, SOPs, local regulations and work in accordance with ICH GCP, EU and UK legislation.
- Conducting Pharmacy visits, ensuring investigational medicinal product (IMP) is handled, stored, dispensed, reconciled and returned/destroyed according clinical trial protocol, SOPs and local policies.
Other
- Participating in study team meetings.
- Working with Data Management to monitor patients and achieve key performance indicators including time to patient lock, time to database lock.
- Increment would be at least a minimum of 15% every six months.
- Relocation charges will be provided to you during your project
- Medicinal, Dental and Vision benefits following 60 days of business.
