Praca: Clinical Research Associate


Ogłoszenie numer: 5300030, 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: kujawsko-pomorskie

 

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.

Wymagania

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.

Oferujemy

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.
APLIKUJ TERAZ

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