Senior Cra - Sponsor Dedicated

2+ years

Not Disclosed

Remote - Europe

10 Sept. 9, 2024

Job Description

Job Type: Full Time 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

Senior Clinical Research Associate I

Syneos Health® is a fully integrated biopharmaceutical solutions organization, driven to accelerate the success of our customers by combining clinical, medical affairs, and commercial expertise to address the needs of today's healthcare market. Our Clinical Development model focuses on placing both the customer and the patient at the center of everything we do. We are committed to simplifying and streamlining our processes, making Syneos Health not only easier to work with but also a rewarding place to build your career.

Join our global team of 29,000 employees across 110 countries, where Work Here Matters Everywhere.

Why Syneos Health: At Syneos Health, we are passionate about developing our people through career progression, training in technical and therapeutic areas, and fostering a supportive and engaged work environment. Our Total Self culture allows you to bring your authentic self to work, building an inclusive atmosphere where everyone feels they belong. We continually work towards creating a diverse and dynamic workplace that our employees and customers want to be a part of.

Key Responsibilities:

Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely), ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and regulatory protocols.
Evaluate site and staff performance, provide recommendations, escalate serious issues, and develop action plans to resolve them.
Ensure informed consent processes are adequately performed and documented for each subject/patient, maintaining confidentiality and prioritizing patient safety.
Conduct Source Document Review of site medical records, verify clinical data accuracy in case report forms (CRFs), and drive query resolution within agreed timelines.
Manage investigational product (IP) inventory, ensuring compliance with protocol requirements, storage, security, and labeling.
Review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF), ensuring accuracy and compliance with archiving regulations.
Support patient recruitment, retention, and data entry, tracking all site activities and project observations.
Serve as a liaison with site personnel and project teams, ensuring sites and staff are trained and compliant with requirements.
Lead and attend investigator meetings, clinical staff meetings, and training sessions.
Contribute to audit readiness, site-level project support, and mentorship for junior CRAs.

Additional Responsibilities for Real World Late Phase (RWLP) Studies:

Provide site support from identification to close-out.
Participate in chart abstraction activities and data collection.
Collaborate with sponsors, affiliates, medical science liaisons, and local staff.
Develop informed consent forms and work with regulatory teams to implement updated guidelines.
Identify operational efficiencies and support process improvements.
Participate in bid defense meetings.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Proficiency in technology and software supporting clinical study data review.
Excellent communication, presentation, and interpersonal skills.
Ability to manage up to 75% travel on a regular basis.

Why Syneos Health: At Syneos Health, we have worked on 94% of all Novel FDA-Approved Drugs and 95% of EMA-Authorized Products over the last five years. With over 200 studies conducted at 73,000 sites and 675,000+ trial patients, we provide an unparalleled platform for professional growth.

Join our Talent Network to stay connected with future career opportunities, and take the initiative to challenge the status quo with us. Learn more about Syneos Health and discover a workplace where your career can truly thrive.

Additional Information: This job description is not exhaustive, and other tasks may be assigned at the company’s discretion. Qualifications may differ based on equivalent experience or skills. Syneos Health is committed to complying with the Americans with Disabilities Act and providing reasonable accommodations when necessary.

Apply now or join our Talent Network to explore more opportunities at Syneos Health.

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Senior Cra - Sponsor Dedicated

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