Cra Ii

2+ years

Not Disclosed

Remote - Europe

10 July 17, 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

Clinical Research Associate II

Company Overview: 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 continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and for.

Work Culture: At Syneos Health, collaboration with passionate problem solvers and innovators is key. We help our customers achieve their goals by being 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:

Passionate about developing our people through career development and progression.
Supportive and engaged line management.
Technical and therapeutic area training.
Peer recognition and total rewards program.
Committed to our Total Self culture, where you can authentically be yourself.
Dedicated to diversity, inclusion, and creating a place where everyone feels like they belong.

Job Responsibilities:

Perform 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.
Use judgment and experience to evaluate the overall performance of site and site staff and provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team and develop action plans.
Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
Demonstrate diligence in protecting the confidentiality of each subject/patient.
Assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site, such as protocol deviation/violations and pharmacovigilance issues.

Per the Clinical Monitoring/Site Management Plan (CMP/SMP):

Assess site processes.
Conduct Source Document Review of appropriate site source documents and medical records.
Verify required clinical data entered in the case report form (CRF) is accurate and complete.
Apply query resolution techniques remotely and on-site, provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
Verify site compliance with electronic data capture requirements.

Additional Responsibilities:

Perform investigational product (IP) inventory, reconciliation, and review storage and security.
Verify the IP has been dispensed and administered to subjects/patients according to the protocol.
Apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labeled, imported, and released/returned.
Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
Reconcile contents of the ISF with the Trial Master File (TMF).
Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
Support subject/patient recruitment, retention, and awareness strategies.
Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
Manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met.
Adapt to changing priorities to achieve goals/targets.
Act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate.
Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
Participate in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project-specific requirements.
Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.

Real World Late Phase (RWLP) Responsibilities:

Use the business card title of Site Management Associate II.
Provide site support throughout the study lifecycle from site identification through close-out.
Knowledge of 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.
Train junior staff as requested.
Identify and communicate out-of-scope activities to Lead CRA/Project Manager.
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy, and Health Care Provider (HCP) associations.

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.
Demonstrate 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% on a regular basis.

About Syneos Health:

Worked with 94% of all Novel FDA Approved Drugs over the past 5 years.
Worked with 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
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, 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 in the Job Description. The Company will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We take into consideration transferrable skills from previous roles and encourage you to join our Talent Network to stay connected to additional career opportunities.

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