Senior Clinical Research Associate - US

About the role

Joining the Optimapharm team means working on diverse and challenging studies, collaborating with experienced professionals around the world, and playing a critical role in shaping the success of clinical trials. You will work 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, and participating in international projects and professional growth.

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 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

Skills

• Strong knowledge of ICH GCP Guidelines
• Experience in oncology clinical trials
• Excellent verbal and written communication skills
• Proactive problem-solving and risk management
• Ability to work independently and in a team
• Interpersonal and negotiation skills

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

Pay

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

Schedule

Not specified