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Cra Ii - Must Have Neurology Expereince - Sponsor Dedicated - Bulgaria (Homebased)

2+ years
Not Disclosed
10 Nov. 13, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and a total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job Responsibilities

  • Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team and develop action plans.
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrate diligence in protecting the confidentiality of each subject/patient.
  • Assess factors affecting subject/patient safety and clinical data integrity at an investigator/physician site such as protocol deviations and pharmacovigilance issues.
  • Conduct Source Document Reviews and verify clinical data entered in the CRF is accurate and complete. Drive query resolution to closure within agreed timelines.
  • May perform investigational product (IP) inventory and reconciliation, ensuring IP is dispensed and administered per the protocol.
  • Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
  • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
  • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associates.
  • Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.

Qualifications

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Strong computer skills and ability to embrace new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.

About Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.