Premier Research is a privately owned, mid-sized global CRO specifically focused on supporting the needs of the smaller Pharmaceutical companies and Biotech organizations and with expertise in Oncology, Rare Disease, Neurology & Medical Devices.
We are looking for talented and energetic Senior Clinical Research Associates to join our team! Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
You will be accountable for:
Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
Planning day-to-day activities for study monitoring and setting priorities by site.
Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
Gauging the quality of clinical deliverables and addressing quality issues with team members.
Maintaining the project tracking system of subjects and site information.
Participating in Investigators’ Meetings as assigned by Project Managers.
Ensuring adherence to study timelines and budgets.
Identifying and escalating potential risks and identifying retraining opportunities for site study teams
Monitors with knowledge of quality/scope/timeline and budget parameters
Works with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
4-year Undergraduate degree from an accredited institution
Must have 7+ years of independent on-site monitoring experience, completion of CRA training program
Ability to travel up to 80% nationally
Experience in coaching/mentoring other CRAs
Experience in monitoring complex trials or global trials or equivalent experience
Knowledge of ICH / GCP regulations
Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
Knowledge of web based communication tools for conferences and any other IT systems required for the job
Strong communication skills, both written and verbal
Excellent team player, collaborative and able to enable an effective team
Ability to multitask and work effectively in a fast-paced environment with changing priorities
Excellent organizational and time-management skills, able to meet deadlines
Self-starter with a lot of common sense and able to act on own initiative
Accountable, dependable and strong commitment
Applies clear and consistent performance standards and handles problems decisively and objectively
Customer service focused in approach to work, both internally and externally
Maintains a positive, results orientated work environment
About Premier Research
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.