Clinical Research Associate II/III - US

Optimapharm . • Boston, MA

33d • Remote

About The Position

Optimapharm is a mid-sized, global Contract Research Organisation (CRO) specializing in Phase I–IV clinical studies, delivering Full-Service and Functional Service Provision (FSP) solutions. With operations in 40+ countries, we enable accelerated regulatory pathways, faster study start-up, and access to diverse patient populations worldwide. As we expand our US Clinical Operations team, we're searching for a CRA II/III who is motivated by quality, driven by purpose, and eager to contribute to innovative clinical research that changes lives. Joining Optimapharm means more than taking on your next role - it's an opportunity to build a long-term career with a global CRO that values growth, development, and excellence. Our structured career pathway provides clear progression and recognition of your expertise: CRA I → CRA II → CRA III → Senior CRA. Here, your dedication is rewarded with meaningful growth opportunities, exposure to diverse studies, and the support needed to reach your full potential.

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, pro-active
• Affinity to work effectively and efficiently in a matrix environment
• A current, valid driver’s license

Responsibilities

• 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
• Identifying and escalating potential risks and identifying retraining opportunities for site personnel
• Preparation of corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow of each, individual CAPA until timely resolution
• Preparation of documents required for EC submissions and notifications, translation of 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
• Administration of site payments in accordance with relevant project instructions

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree