Clinical Research Associate II/III - US

About the role

Optimapharm is a mid-sized, global Contract Research Organisation (CRO) that specializes in Phase I–IV clinical studies. The company aims to accelerate regulatory pathways, facilitate faster study start-up, and provide access to diverse patient populations worldwide.

Responsibilities

- Working in a successful company that’s growing and developing every day - Being part of a clinical research team that transforms science into hope for patients - International projects and professional growth - Company that supports life balance - Company with healthy culture - Working with a highly experienced team of clinical research professionals - Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits - Manage assigned sites by regular contact with site personnel to ensure site compliance, adequate enrolment and understanding of study requirements - Independently perform CRF review; query generation and resolution against established data review guidelines or data management systems as applicable - Identify and escalate potential risks and identify retraining opportunities for site personnel - Prepare corrective and preventive (CAPA) plans for issues identified during monitoring activities and proactively follow up on each, individual CAPA until timely resolution - Prepare documents required for EC submissions and notifications, translate study-related documents (where applicable), and other tasks as instructed by the supervisor - Independently negotiate study budgets with potential investigators/institutions and assist with the execution of site contracts as applicable - Administer site payments in accordance with relevant project instructions

Requirements

- University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree - At least 2 years of independent clinical trial monitoring experience - High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research - Computer proficiency is mandatory - Ability to read, analyze, and interpret common scientific and technical journals - Excellent verbal and written communication skills - Very good interpersonal and negotiation skills - Ability to work independently, proactive - Affinity to work effectively and efficiently in a matrix environment - A current, valid driver’s license

Qualifications

- Competitive salary - Competitive PTO entitlement - Health insurance, including vision and dental plans, to meet your and your family's needs - Comprehensive pension plan to maximize savings and prepare confidently for the future - Employee engagement programs - Well-being initiatives - Training and development program - Fast-paced career path progression

Skills

- None listed

Benefits

- None listed

Pay

Competitive

Schedule

Not specified