Clinical Research Monitoring (CRA)

Location: Remote
Optimapharm is a mid-sized, global Contract Research Organisation (CRO) turning science into hope through agile, patient-focused clinical development. We specialise in Phase I-IV clinical studies, delivering Full-Service and Functional Service Provision (FSP) solutions that help sponsors move faster and execute with confidence.
With operations in 40+ countries and 2x the patient reach of the average mid-sized CRO, we enable accelerated regulatory pathways, faster study start-up, and access to diverse patient populations worldwide. At Optimapharm, you'll contribute to meaningful clinical research while growing your career in a dynamic, people-focused, global environment.
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.
Our structured career pathway provides clear progression and recognition of your expertise: Here, your dedication is rewarded with meaningful growth opportunities, exposure to diverse studies, and the support needed to reach your full potential.
Being part of a clinical research team that transforms science into hope for patients
International projects and professional growth
Working with a highly experienced team of clinical research professionals
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
Well-being initiatives
Training and development program
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
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
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
By joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.