Stanowisko pracy:


Praca: Clinical Research Associate

Ogłoszenie numer: 5300048, z dnia 2021-08-20

Comac Medical

Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a full-service providers of CRO and SMO with headquarter in Sofia, Bulgaria.


Clinical Research Associate

Miejsce pracy: opolskie


Opis stanowiska

What is expected to be done:

  • Conducts feasibility studies and site qualification visits;
  • Develops and ensures strong site relationship through all phases of the trial;
  • Gains in-depth understanding of the study protocol and related procedures;
  • Prepares study documentation e.g. draft protocols, draft CRFs;
  • Collects, reviews, and monitors required regulatory documentation;
  • Communicates with Investigators and site staff on issues related to protocols;
  • Conducts recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance;
  • Performs remote and on-site monitoring & oversight activities;
  • Identifies, assesses and resolves site performance, quality or compliance problems
  • Escalates if necessary, by following CRA Escalation Pathway in collaboration with CTL/CMM/PL;
  • Assists in planning and execution of Investigator Meetings or other study related meetings;
  • Assume additional responsibilities as required by Project Manager.


What is required for the role?

  • Graduate or postgraduate degree, preferably in the filed of Biology, Pharmacy, Chemistry or other relevant;
  • At least 3 years of experience as a Clinical Research Associate/Clinical Monitor;
  • Excellent knowledge of clinical research process;
  • Good knowledge of all functional areas of clinical trial management;
  • Working knowledge of current ICH/GCP guidelines and applicable country-specific regulations;
  • Excellent organizational, communication (verbal and written)
  • Positive attitude and ability to interact with various levels of personnel
  • Good analytical and problem-solving skills;
  • Ability to travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 30%)
  • Ability to keep tight deadlines and work in a dynamic environment;
  • Working knowledge of Word, Excel, and Power Point
  • Fluency in English language.


Why to join Comac Medical?

  • Great team of knowledgeable, high-achieving and experienced professionals;
  • International and diverse work atmosphere;
  • Challenging projects in a different therapeutical area as well as in early phases;
  • Opportunity to enrich professional skills and progress in career development;
  • Competitive remuneration;
  • Professional trainings.
Prosimy o dopisanie klauzuli: Wyrażam zgodę na przetwarzanie moich danych osobowych dla potrzeb niezbędnych w procesie rekrutacji.

Najnowsze oferty pracy

SRN Integration Engineer [rekrutacja online]


Localization: Wrocław About the project Our team is working on technical support in variety of technologies from Nokia Radio, CS& PS Core, and Server products. So, if you have an experience in these products and you have a huge willingness to...
Dodane: dzisiaj

Product Provisioning Specialist [rekrutacja online]


Localization: Wrocław About the project Product Provisioning Specialist works as part of the Product Program / assists the Product Manager acting as the voice of the customer to communicate the customers requirements and the requirements coming...
Dodane: dzisiaj

Order Management Specialist with Italian

Genpact PL

Responsibilities Ensure customer orders flow through the ERP system and transmit signals to Logistics for delivery Ensure creation of documents (invoice, delivery note) Offer all needed information for Customer Facing and Collections specialists,...
Dodane: dzisiaj

Senior Data Analyst

Objectivity Sp. z o.o.

Your role: Understanding and gathering business needs for data insights. Designing data information layer. Analysing data sources and model data following best practices. Developing dashboards and reports in BI tools. Working in a way that uses...
Dodane: dzisiaj