Clinical Research Associate

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.