Senior Clinical Research Associate Ii

2-6 years

Not Disclosed

Remote - Europe

10 July 3, 2024

Job Description

Job Type: 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

Senior Clinical Research Associate II (Freelance Role, 6-Month Contract)

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

Our Clinical Development model centers around our customers and patients, striving to simplify and streamline our processes. Whether you join us through 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.

Why Syneos Health?

Career Development: We are passionate about developing our people through career progression, supportive line management, and technical and therapeutic area training.
Total Self Culture: We are committed to our Total Self culture, which unites us globally and allows you to authentically be yourself.
Diverse and Inclusive Workplace: We are continuously building a company that everyone wants to work for and our customers want to work with. By bringing together diverse thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.

Job Responsibilities

Conduct site qualification, site initiation, interim monitoring, site management, and close-out visits (on-site or remotely) ensuring compliance with regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practices (GPP) and protocol requirements.
Evaluate overall performance of sites and site staff, providing recommendations and escalating serious issues to the project team.
Maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Verify the process of obtaining informed consent and ensure confidentiality of each subject/patient.
Assess factors affecting subject/patient safety and clinical data integrity at investigator/physician sites.
Perform Source Document Review, verify clinical data accuracy, and drive query resolution to closure.
Conduct IP inventory, reconciliation, and review storage and security according to protocols.
Review and reconcile Investigator Site File (ISF) with the Trial Master File (TMF).
Document activities through confirmation letters, follow-up letters, trip reports, and communication logs.
Support subject/patient recruitment, retention, and awareness strategies.
Manage site-level activities to ensure project objectives, deliverables, and timelines are met.
Act as a primary liaison with study site personnel and ensure all team members are trained and compliant.
Prepare for and attend Investigator Meetings and sponsor face-to-face meetings.
Provide guidance towards audit readiness and support preparation for audits.
Supervise, train, and mentor junior CRAs and perform training and sign-off visits.
Participate in business development proposals and defense meetings under supervision.

Additional Responsibilities for Real World Late Phase (RWLP)

Support site activities throughout the study lifecycle.
Conduct chart abstraction and data collection.
Collaborate with the Sponsor, medical science liaisons, and local country staff.
Train junior staff and identify operational efficiencies and process improvements.
Develop informed consent forms and collaborate with the RWLP Regulatory team.
Participate in bid defense meetings and provide input into Requests for Proposals (RFPs).
Develop site management strategies and participate in Case Report Form design.

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.
Proficient in computer skills and new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to manage travel up to 75% regularly.
Strong critical thinking skills and adaptability to changing priorities.

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 are not exhaustive. The company may assign other tasks, duties, and job responsibilities at its discretion. Equivalent experience, skills, and/or education will also be considered. The company is committed to compliance with the Americans with Disabilities Act and providing reasonable accommodations to assist employees or applicants in performing essential job functions.

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