(INACTIVE) - CLINICAL RESEARCH ASSOCIATE

• Medicine and health
• Skopje
• komak medikal dooel
• 14-02-2023

Job details

Great job opportunity for a CLINICAL RESEARCH ASSOCIATE 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.

 Currently we are looking for a proven professional to obtain the role with a flying start and deep dive into the daily tasks with confidence and knowledge at our local office in Skopje, Macedonia

 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;

 Core strengths of Comac Medical

 Proven track record for quality and delivery;

·         Established and trusted relationships with KOLs;

·         Motivated, capable and dedicated team;

·         Global full-service capabilities;

 If you are interested, challenged and convinced that the job opportunity is exactly for you, do not hesitate and send your detailed resume in English at bojana.dzurovska@comac-medical.com

Only the shortlisted candidates will be contacted in a timely manner.