Sponsor Dedicated Cra I

2+ years

Not Disclosed

Remote - Europe

10 Aug. 8, 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

Sponsor Dedicated CRA I - Home Based ITA

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

Our Clinical Development model centers the customer and the patient at the heart of everything we do. We are constantly seeking ways to simplify and streamline our work, making Syneos Health easier to work with and for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you will 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 dedicated to developing our people through career progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a total rewards program. Our commitment to our Total Self culture means you can authentically be yourself. This culture unites us globally, and we are committed 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. When we bring together diverse thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels they belong.

Job Responsibilities

Perform site qualification, site initiation, interim monitoring, site management, and close-out visits (on-site or remotely), ensuring regulatory, ICH-GCP, and protocol compliance. Evaluate overall performance of site and site staff, provide site-specific recommendations, and develop action plans with guidance.
Verify the process of obtaining informed consent for each subject/patient, demonstrating diligence in protecting confidentiality. Assess factors affecting patient safety and clinical data integrity, such as protocol deviations/violations and pharmacovigilance issues.
Assess site processes, conduct Source Document Reviews, verify accuracy and completeness of clinical data, and apply query resolution techniques.
Utilize hardware and software to support effective clinical study data review and capture. Verify site compliance with electronic data capture requirements.
Perform investigational product (IP) inventory, reconciliation, and review of storage and security. Ensure IP is dispensed and administered according to the protocol.
Routinely review the Investigator Site File (ISF) for accuracy and completeness. Reconcile ISF contents with the Trial Master File (TMF) and ensure essential documents are archived as per guidelines.
Document activities via confirmation letters, follow-up letters, trip reports, and communication logs. Support subject/patient recruitment and retention strategies.
Understand project scope, budgets, and timelines; manage site-level activities and communication to ensure project objectives and deliverables are met.
Act as a primary liaison with project site personnel or collaborate with another CRA or Central Monitoring Associate (CMA). Ensure all assigned sites and project-specific site team members are trained and compliant.
Prepare for and attend Investigator Meetings and sponsor meetings. Participate in global clinical monitoring/project staff meetings and clinical training sessions.
Provide site and project-level guidance for audit readiness and support preparation and follow-up actions.

For Real World Late Phase:

Use the business card title of Site Management Associate I.
Provide site support throughout the study lifecycle, from site identification to close-out.
Understand local requirements for real-world late-phase study designs.
Conduct chart abstraction activities and data collection.
Collaborate with Sponsor affiliates, medical science liaisons, and local country staff.

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.
Good computer skills and the 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 five 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 your role, 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.

Additional Information

Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities at its sole discretion and with no prior notice. Equivalent experience, skills, and/or education will also be considered, so qualifications of incumbents may differ from those listed. The Company will determine what constitutes as equivalent to the qualifications described above. Nothing herein should be construed to create an employment contract.

We are committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations to assist employees or applicants in performing the essential functions of the job.

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Sponsor Dedicated Cra I

Job Description

Sponsor Dedicated CRA I - Home Based ITA

Why Syneos Health

Job Responsibilities

Qualifications

Get to Know Syneos Health

Additional Information

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