Senior Clinical Research Associate

4 weeks ago

Addison, United States Optimapharm d.o.o. Full time
Location: home-based

Who we are?

Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients' lives. Optimapharm's key priorities are our people and consistently exceeding our client's expectations.

With 27 strategically located offices, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.

In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.

We are looking for a Senior CRAto join our Clinical Operations teamand support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.

What do we offer?

  • Working in a successful company that's growing and developing every day
  • Working with a highly experienced team of clinical research professionals
  • International projects and professional growth
  • Competitive benefit package
  • Home-based position
Who are we looking for?

Qualifications and Experience
  • University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
  • At least 5 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
Your 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


By joining our fast-growing and prosperous team, you will have an excellent opportunity for further personal growth and career development.

If you would be interested in joining the Optimapharm team, please send your CV and note that only shortlisted candidates who meet the requirements will be contacted for the further selection process.

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