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. CRAs usually work for pharmaceutical companies, hospital research departments, or clinical contract agencies.
- Participating in study team meetings.
- 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.
- Working with Data Management to monitor patients and achieve key performance indicators including time to patient lock, time to database lock.
BSc/BA in Computer Science, Engineering or relevant field; graduate degree in Data Science or other quantitative field is preferred
- 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.
- Medical coverage qualified following 60 days of business.
- Present moment and long-haul handicap following 60 days of work.
- 401k retirement benefits plan qualified following half a year of work.
Only for international candidates on OPT/CPT:
- Employer’s Confirmation Letter/CPT Letter/Offer Letter will be provided, which you need to submit to your university within 90 days of the start of your OPT.
- OPT Extension Letter will be provided to those candidates who are qualified for STEM extension.
- H1B Sponsorship will be provided to OPT and CPT candidates only once they join our client’s project.
- Pre-job Training with Experienced Trainers.
- Assignments & Case Studies provided during training.
- Mock sessions before interviews
- Multiple interview rounds with different clients.
- Visa Sponsorship
- Training completing certificates