- Company Name
- ClinChoice
- Job Title
- Clinical Research Associate II (CRA II)
- Job Description
-
**Job title**
Clinical Research Associate II (CRA II)
**Role Summary**
Support the planning, execution, and close‑out of pharmaceutical clinical trials, ensuring adherence to ICH‑GCP, regulatory requirements, and sponsor SOPs. Act as primary site liaison, manage trial documentation, monitor activities, and coordinate safety reporting. Provide independent project oversight while collaborating with cross‑functional teams.
**Expectations**
- Deliver trial milestones on schedule and within budget.
- Maintain accurate, compliant trial documentation and databases.
- Serve as trusted resource for trial stakeholders.
- Demonstrate professionalism in client‑facing interactions.
- Make autonomous decisions on routine issues; seek guidance on complex matters.
- Uphold health, safety, and regulatory compliance at all times.
**Key Responsibilities**
- Conduct feasibility assessments, site selection, and initiation.
- Serve as main contact for study sites, IRBs/ECs, and vendors.
- Prepare and update study protocol, consent forms, CRFs, monitoring plans, investigator brochures, and annual reports.
- Register trials on clinicaltrials.gov and manage results posting.
- Order, track, and manage investigational product and materials.
- Plan and execute site visits: qualification, initiation, interim, and close‑out.
- Monitor site compliance, data collection, and adverse event reporting.
- Assist in investigator agreements, payment processing, and budget tracking.
- Review clinical data for statistical readiness.
- Coordinate safety activities, develop Safety Management Plans, handle SAAs, and maintain study safety inbox.
- Generate safety and study progress reports for stakeholders, investigators, and regulatory authorities.
**Required Skills**
- Strong written and verbal communication.
- Excellent organizational and project management.
- In‑depth knowledge of ICH‑GCP, FDA, EMA, and local regulations.
- Experience in clinical trial monitoring and site management.
- Proficiency with clinical data and safety management systems.
- Ability to analyze data and prepare reports for statistical review.
- Team orientation and stakeholder collaboration.
- Problem‑solving and independent decision‑making.
**Required Education & Certifications**
- Bachelor’s degree in life sciences, nursing, pharmacy, or related field (advanced degree preferred).
- 2–4 years of clinical research experience, including monitoring.
- Current ICH‑GCP training; certification such as CCRP, CCP, or equivalent highly valued.