Senior CRA

Reposted 14 Hours Ago
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Skopje, Skopski, MKD
In-Office
Senior level
Pharmaceutical
The Role
Lead and perform onsite monitoring (SIV, RMV, COV) for Phase II/III studies, conduct CRF review and source verification, manage site communication, support feasibility and regulatory submissions, liaise with vendors and internal teams, and prepare for audits and inspections.
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Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global, mid-size company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

    Job Description

    We are looking for an experienced Senior CRA to support us with the following responsibilities in North Macedonia:

    • Conduct and report SIV, RMV, COV onsite monitoring visits
    • Perform CRF review, source document verification and query resolution
    • Be responsible for site communication and management
    • Be a point of contact for in-house support services and vendors
    • Communicate with internal project teams regarding study progress
    • Participate in feasibility research
    • Support regulatory team in preparing documents for study submissions
    • Prepare and participate in audits and inspections

    Qualifications

    • College/University degree in Life Sciences or an equivalent combination of education, training & experience
    • Independent on-site monitoring experience
    • Experience in all types of monitoring visits in Phase II and/or III
    • Full working proficiency in English and Macedonian is essential.
    • Proficiency in MS Office applications
    • Ability to plan, multitask and work in a dynamic team environment
    • Excellent communication, collaboration, and problem-solving skills
    • Ability to travel
    • Valid driver’s license

    Additional Information

    This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

    Skills Required

    • College/University degree in Life Sciences or equivalent
    • Independent on-site monitoring experience
    • Experience in monitoring visits for Phase II and/or III studies
    • Full working proficiency in English and Macedonian
    • Proficiency in MS Office applications
    • Ability to plan, multitask and work in a dynamic team environment
    • Excellent communication, collaboration, and problem-solving skills
    • Ability to travel
    • Valid driver's license
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    The Company
    HQ: Zug
    1,939 Employees
    Year Founded: 1995

    What We Do

    PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

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