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Clinical research associate II
Comac Medical Ltd
Place of work
Remote work
Remote work
Contract type
full-time, agreement-based (Temporary jobs)
full-time, agreement-based (Temporary jobs)
Wage (gross)
From 2 000 EUR/month
From 2 000 EUR/month
Information about the position
Job description, responsibilities and duties
Great job opportunity for a CLINICAL RESEARCH ASSOCIATE II for one of the most reputable, full-service providers of CRO and SMO.
Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.
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;
• Performs remote 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;
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 keep tight deadlines and work in a dynamic environment;
• Working knowledge of Word, Excel, and Power Point
• Fluency in English language
Established in 1997, with locations in Central & Eastern Europe and 290 full-time dedicated professionals, COMAC MEDICAL is a recognized leader in clinical research and provides innovative and non-conventional solutions of high quality for pharmaceutical industry.
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;
• Performs remote 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;
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 keep tight deadlines and work in a dynamic environment;
• Working knowledge of Word, Excel, and Power Point
• Fluency in English language
Employee perks, benefits
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;
• 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;
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
University education (Master's degree)
Language skills
English - Advanced (C1)
Number of years of experience
3
Advertiser
Brief description of the company
COMAC MEDICAL is a Full Service CRO/SMO providing a broad network of clinical research sites in the best healthcare institutions across Central and Eastern Europe
Number of employees
250-499 employees
ID: 4088181
Dátum zverejnenia: 24.5.2021
2021-05-24
lokalita: Remote work Pozícia: Clinical Research Associate Spoločnosť: Comac Medical Ltd
Základná zložka mzdy (brutto): 2 000 EUR/month