Senior Clinical Research Associate - US

Optimapharm is a mid-sized, global Contract Research Organisation (CRO) that specializes in Phase I–IV clinical studies, delivering Full-Service and Functional Service Provision (FSP) solutions to help sponsors move faster and execute with confidence.

About the role

We are seeking a Senior CRA who is committed to clinical excellence, passionate about mentoring others, and driven by the opportunity to help bring innovative treatments to patients faster. The ideal candidate will work on diverse and challenging studies, collaborate with experienced professionals around the world, and play a critical role in shaping the success of clinical trials within a supportive and dynamic environment.

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
• 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

Requirements

• A university degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
• At least 3-5 years of independent clinical trial monitoring experience in oncology
• 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, proactively
• Affinity to work effectively and efficiently in a matrix environment
• A current, valid driver’s license
• 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 proactively follow up on 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

Qualifications

• University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
• At least 3-5 years of independent clinical trial monitoring experience in oncology
• 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, proactively
• Affinity to work effectively and efficiently in a matrix environment
• A current, valid driver’s license

Skills

• Strong clinical research background
• Knowledge of ICH GCP Guidelines and regulatory requirements
• Excellent communication and interpersonal skills
• Proactive problem-solving and risk management abilities
• Ability to work independently and in a team environment
• Proficiency in computer applications

Benefits

• Competitive salary
• Competitive PTO entitlement
• Health insurance, including vision and dental plans
• Comprehensive pension plan
• Employee engagement programs
• Well-being initiatives
• Training and development program
• Fast-paced career path progression

Pay

Compensation is competitive and final offers will reflect each candidate’s experience, skills, and qualifications.

Schedule

Flexible schedule to accommodate international projects and personal commitments.