Clinical Research Associate

• Conducts feasibility studies and site qualification visits;

• Develops and ensures a strong site relationship through all phases of the trial;

• Gains in-depth understanding of the study protocol and related procedures;

• Prepares study documentation eg 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.

• 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;

• Ability to keep tight deadlines and work in a dynamic environment;

• Working knowledge of Word, Excel, and Power Point;

• Fluency in English language.

• Great team of knowledgeable, high-achieving and experienced professionals;

• International and diverse working atmosphere;

• Challenging projects in a different therapeutical area as well as in early phases;

• Opportunity to enrich professional skills and progress in career development.

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