Sr Cra I

5+ years

Not Disclosed

Remote - Europe

10 Aug. 5, 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, 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

Join Our Team at Syneos Health: Senior Clinical Research Associate I

About Syneos Health:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address modern market realities. Our Clinical Development model centers on the customer and the patient, continuously striving to simplify and streamline our work to make Syneos Health easier to work with and 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. Our Total Self culture, where you can authentically be yourself, unites us globally. We are dedicated to taking care of our people and 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 like they belong.

Job Responsibilities:

Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely), ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP), and protocol compliance.
Use judgment and experience to evaluate the overall performance of sites and site staff, provide recommendations, and communicate serious issues to the project team, developing action plans as needed.
Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verify that the process of obtaining informed consent is adequately performed and documented for each subject/patient.
Protect the confidentiality of each subject/patient and assess factors that might affect subject/patient safety and clinical data integrity.
Conduct Source Document Review of site source documents and medical records.
Verify clinical data entered in the case report form (CRF) is accurate and complete.
Apply query resolution techniques and provide guidance to site staff to drive query resolution to closure within agreed timelines.
Manage investigational product (IP) inventory, reconciliation, and reviews, ensuring compliance with GCP/local regulations and organizational procedures.
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.
Support subject/patient recruitment, retention, and awareness strategies.
Enter data into tracking systems to monitor observations, ongoing status, and action items to resolution.
Manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met.
Act as primary liaison with project site personnel and ensure all assigned sites and project-specific site team members are trained and compliant.
Participate in global clinical monitoring/project staff meetings and attend clinical training sessions.
Provide guidance at the site and project level towards audit readiness and support audit preparations and follow-up actions.
Train or mentor junior CRAs and perform training and sign-off visits as assigned.

Additional Responsibilities for Real World Late Phase (RWLP):

Support sites throughout the study lifecycle from site identification through closeout.
Understand local requirements for real world late phase study designs.
Conduct chart abstraction activities and data collection.
Collaborate with Sponsors, medical science liaisons, and local country staff.
Identify and communicate out-of-scope activities to Lead CRA/Project Manager.
Suggest potential sites based on local knowledge.
Identify operational efficiencies and process improvements.
Develop country-level informed consent forms.
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared.
Participate in bid defense 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.
Proficiency in computer skills and ability to embrace new technologies.
Excellent communication, presentation, and interpersonal skills.
Basic level of critical thinking skills.
Ability to manage up to 75% travel on a regular basis.

About 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 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.

Additional Information:

Tasks, duties, and responsibilities 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. The Company will determine what constitutes as equivalent to the qualifications described above. This job description should not 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 comply fully 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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations to assist employees or applicants to perform essential functions of the job.

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Syneos Health

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