Clinical Research Associate, Optimapharm Nordic Oy, Otaniemi, Espoo

Who we are?
Established in 2006, OPTIMAPHARM is a full-service mid-sized European CRO, that provides tailored solutions and has high-level expertise in managing trials across Europe, with unrivaled access to patients. Our operational excellence and customer-focused approach have led to us achieving a 95% repeat business level.

After 10 years of strong and successful collaboration, in December 2021, OPTIMAPHARM acquired Crown CRO, a highly reputable full-service CRO from Finland, and since then, significantly strengthened its presence in the Nordic and Baltic regions.

OPTIMAPHARM’s highly experienced team of experts supports a comprehensive network of 25 local offices and operations in 37 countries.

Having offices across Europe, as well as having a network of preferred partners, OPTIMAPHARM is well qualified to manage trials in Europe, Israel, and the US, supporting Biotech, Pharmaceutical, and Medical Devices companies in reaching large patient populations in various indications whilst achieving competitive start-up timelines at competitive prices.

We are looking for a CRA to join our team in Finland and 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 changing every day
-Working with a highly experienced team of the clinical research professionals
-International projects and professional growth
-Performance bonus
-Training opportunities
-Possibility to work remotely for a part of the week

Who are we looking for?

Qualifications and Experience

-University degree, preferably in medical or life sciences; nursing education or other relevant healthcare college degree
-Possibility to work remotely for a part of the weekdegree
-At least 1 year 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
-Fluent in local language and English; both, written and verbal
-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 would be advantageous

Your responsibilities

-Perform routine site visits independently, including pre-study, initiation, interim monitoring and closeout visits
-Manage assigned sites by regular contacts 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 in English and note that only shortlisted candidates that meet the requirements will be contacted for the further selection process.