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Aplikacija

CRA II/Senior, Serbia Puno radno vreme

na Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health) u Beograd (Poslato na 02-07-2018)

CRA II/Senior, Serbia

Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)

Job description

CRA II/Senior
Belgrade, Serbia
Home-based or office-based
Permanent contract
Here at Syneos Health we are currently recruiting for a CRA II or Senior CRA to be based in Belgrade, Serbia.

Job Details

Main responsibilities include but are not limited to:
Monitoring
Critically evaluates adequacy of investigator sites (qualifications, facilities, equipment and performance). Performs all tasks required for onsite/remote monitoring including but not limited to source document review (SDR) and source document verification (SDV).
Completes and submits monitoring visit reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work.
Ensures all assigned sites are fully trained.
Extensive travel may be required, 50% to 75% on a regular basis.

Reporting and Tracking

Maintains site performance metrics and implements action plans for sites not meeting expectations with minimal guidance.
Maintains up to date information within the deployed CTMS.
Data Management— Uses analytical thinking to review data recorded in source documents for accuracy and completeness, and in accordance with the clinical monitoring and associated plans. Verifies that the clinical data entered in the case report form (CRF) is accurate and complete.
Investigational Product—Performs IP inventory, reconciliation and reviews storage and security. Verifies that the IP has been dispensed and administered to subjects according to the protocol. Verifies process and identifies any issues or risks associated with blinded or randomized information related to IP.
Documentation and Record keeping— Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with that of the trial master file (TMF
Communication—Maintains effective, accurate, and timely communication with site staff and project team, ensures appropriate issue escalation.
Attends clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements
May provide training or mentorship to more junior-level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.

Eligibility/Qualifications/Requirements

The ideal candidate will need the following experience / skills to be considered:
MD Degree is preferred, life sciences degree is mandatory
Min. 2 years’ experience as a CRA with a thorough understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines.
Comfortable in navigation within, and able to assist junior staff in: CTMS systems, Data Platforms for assigned projects, Microsoft Suite: Excel, Word, Power Point, Outlook, Site EMR systems.
Ability to handle multiple tasks to meet deadlines in a dynamic environment
We have a comprehensive benefits package and offer highly competitive remuneration.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV.
To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/

Please be advised that only selected candidates will be contacted back.
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

Primary Location
Europe – SRB-Belgrade-Resavska-23
Job
Clinical Monitoring
Schedule
Full-time
Travel
Yes, 50 % of the Time
Employee Status
Regular

Application link



Pregledano: 457 puta
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