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Cra Ii - Must Have Immuno-Inflammation 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

Description

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 to change 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

  • Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
  • Verifies informed consent processes and documentation for subjects/patients.
  • Assesses site performance, including evaluating clinical data integrity and safety factors.
  • Ensures clinical data entered in case report forms (CRFs) is accurate and complete.
  • Supports investigational product inventory and reconciliation processes.
  • Ensures compliance with electronic data capture requirements and assists with data review.
  • Prepares documentation such as trip reports, follow-up letters, and communication logs in accordance with SOPs and the Clinical Monitoring/Site Management Plan.
  • Manages site-level activities and communication to meet project objectives, deliverables, and timelines.
  • Supports recruitment and retention strategies for study participants.

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 applicable regulatory requirements.
  • Must demonstrate good computer skills and ability to embrace new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% regularly.

Get to know Syneos Health
Over the past 5 years, we’ve 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.

At Syneos Health, you’ll take initiative and challenge the status quo in a highly competitive and ever-changing environment.

Additional Information
Tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may assign other tasks or responsibilities as necessary. The company will also consider equivalent experience, skills, or education. Nothing in this job description should be construed as creating an employment contract.