Sponsor Dedicated Sr Cra Ii / Site Relationship Lead

5+ 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

Job Description

Sponsor Dedicated Sr CRA II / Site Relationship Lead - Home Based ITA

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into actionable outcomes to address modern market realities. Our Clinical Development model places the customer and patient at the center of everything we do. We continually seek ways to simplify and streamline our work, making Syneos Health easier to work with and for.

Join us in either a Functional Service Provider partnership or a Full-Service environment and collaborate with passionate problem solvers. We innovate as a team to help our customers achieve their goals, driven by our passion to change lives.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health

We are committed to 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 unites us globally, dedicated to taking care of our people. We continuously build 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, 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, Good Pharmacoepidemiology Practices (GPP), and protocol compliance.
Evaluate site and staff performance and provide recommendations for site-specific actions; communicate/escalate serious issues to the project team and develop action plans.
Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
Verify the process of obtaining informed consent and protect subject/patient confidentiality.
Assess factors affecting subject/patient safety and clinical data integrity at investigator/physician sites.
Conduct Source Document Review of site source documents and medical records.
Verify the accuracy and completeness of clinical data entered in the case report form (CRF).
Apply query resolution techniques and provide guidance to site staff, driving query resolution to closure within agreed timelines.
Verify site compliance with electronic data capture requirements.
Perform investigational product (IP) inventory, reconciliation, and review storage and security.
Ensure the accuracy, timeliness, and completeness of the Investigator Site File (ISF) and reconcile contents with the Trial Master File (TMF).
Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other project documents.
Support subject/patient recruitment, retention, and awareness strategies.
Track all observations, ongoing status, and action items to resolution.
Manage site-level activities and communication to meet project objectives, deliverables, and timelines.
Act as the primary liaison with study site personnel or collaborate with the Central Monitoring Associate.
Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
Provide guidance for audit readiness standards and support audit preparation and follow-up actions.
Provide direct supervision, training, and/or mentorship to more junior CRA staff.
Perform training and sign-off visits for junior CRA staff as assigned.
May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager.

For Real World Late Phase (RWLP)

Use the business card title of Sr. Site Management Associate II.
Support site throughout the study lifecycle from identification to close-out.
Knowledge of local requirements for real world late phase study designs.
Conduct chart abstraction activities and data collection.
Collaborate with Sponsor and other affiliates, medical science liaisons, and local country staff.
Train junior staff.
Identify and communicate out-of-scope activities.
Suggest potential sites based on local knowledge of treatment patterns and patient advocacy.
Identify operational efficiencies and process improvements.
Develop study and country-level informed consent forms.
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared.
Participate in bid defense meetings.
Provide input into Requests for Proposals (RFPs), scope, and budgeting.
Develop site management strategy.
Participate in Case Report Form design and edit check development.

Qualifications

At least four years of experience as a CRA certified according to Italian M.D 15 Nov 2011.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Proficient computer skills and the ability to embrace new technologies.
Excellent communication, presentation, and interpersonal skills.
Moderate level of critical thinking skills.
Ability to manage required travel of up to 75% on a regular basis.

Get to Know Syneos Health

In 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 will take the initiative and challenge the status quo with us 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 responsibilities at its sole discretion. Equivalent experience, skills, and/or education will also be considered. The Company will determine what constitutes as equivalent to the qualifications described above. This description should not be construed as creating an employment contract. Occasionally, required skills/experiences for jobs are expressed briefly. This language 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 providing reasonable accommodations to assist employees or applicants in performing 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 consider transferable skills from previous roles and invite you to join our Talent Network to stay connected to additional career opportunities.

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Job Description

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