Home-based CRA II (Turkey)

Company Name: Syneos Health Clinical Solutions (Previously INC Research/inVentiv Health)
Location: Turkey

Job Summary

The Clinical Research Associate II (CRA II) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Performs all tasks routinely and independently, seeking guidance as needed.

Job Responsibilities

• Ensure for Country trial start up activities, i.e. Translation of study documents, HA submission, and Clinical supplies check-up/import at project level
• Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected
• Support the site initiation and training executed by CRAs.
• Ensure Country Specific master file and facilitate preparation and monitor the collection of site level documents by CRAs; resolve problems as required
• Ensure Planning and Set up the local trial timeline with CRA for the key metrics i.e. IRB submission, site contract, site initiation, patient recruitment, routine monitoring, close out activities
• Monitor on status of planned versus actual patient recruitment/timeline and implement strategies to correct deviations from proposed plan according to metrics.
• Ensure the site level compliance/adequate site management through co-monitoring visit with the CRA if necessary
• Liaise with global TA/BU clinical teams and CPOs to identify issues and mediate resolution in a timely manner at a project level.
• Review study monitoring reports which monitor generated, as assigned.
• Identify project and Clinical Operations issues that will impact the successful conduct of a trial and bring to the attention of the GMO Head for information and/or resolution in a timely manner
• Supervise the monitor of the implementation of site closeout activities.
• Act as local and/or global CRA lead and author global monitoring plan, as assigned.
• Act as a mentor to new associates for purposes of field training, as assigned.
• Work to coordinate for audits if necessary
• Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement.
• Basically, conduct site level activities as a CRA which she/he is responsible for: execute site initiation and training, implement total site management including monitoring visits and closeout activities
  
  

Qualification Requirements

• Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus prior clinical research experience
• Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirement
• Excellent communication, interpersonal, and change management skills
• Strong time management, technical and organizational skills. Ability to work independently and within a team environment.
• Must demonstrate good computer skills and be able to embrace new technologies
• Ability to travel as necessary (up to 50%)
  
  

Disclaimer

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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Why Syneos Health?

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. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Primary Location

Middle East & North Africa - TUR-Client-Based

Job

Clinical Monitoring

Schedule

Full-time

Travel

Yes, 50 % of the Time

Employee Status

Regular

• Seniority level

  Entry level

• Employment type

  Full-time

• Job function

  ResearchScience

• Industries

  BiotechnologyPharmaceuticalsResearch