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Sr CRA I
2 months ago
Job Title: Senior Clinical Research Associate I
Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model puts the customer and patient at the center of everything we do, simplifying and streamlining our work to make us easier to work with and for.
We're looking for a Senior Clinical Research Associate I to join our team. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials, from site qualification to close-out. You will work closely with project teams, investigators, and other stakeholders to ensure compliance with regulatory requirements, ICH-GCP guidelines, and company SOPs.
Key Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory compliance and protocol adherence.
- Verify informed consent processes and maintain confidentiality of subject/patient data.
- Assess site processes, conduct source document reviews, and verify clinical data accuracy and completeness.
- Apply query resolution techniques and provide guidance to site staff to drive query resolution to closure within agreed timelines.
- Perform investigational product inventory, reconciliation, and reviews, and verify IP dispensing and administration according to protocol.
- Review Investigator Site Files (ISF) for accuracy, timeliness, and completeness, and reconcile contents with Trial Master Files (TMF).
- 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, and enter data into tracking systems as required.
- Understand project scope, budgets, and timelines, and manage site-level activities 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 with applicable requirements.
- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings, and participate in global clinical monitoring/project staff meetings.
- Provide guidance towards audit readiness standards and support preparation for audit and required follow-up actions.
Additional Responsibilities:
- Site support throughout the study lifecycle from site identification through close-out.
- Knowledge of local requirements for real-world late-phase study designs.
- Chart abstraction activities and data collection.
- Collaborate and build relationships with Sponsor and other affiliates, medical science liaisons, and local country staff.
- 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 associations.
- 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.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
About Syneos Health:
Over the past 5 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. We're a company that takes the initiative and challenges the status quo in a highly competitive and ever-changing environment.
Why Join Us:
We offer a dynamic and supportive work environment that fosters career development and progression. Our Total Self culture is what unites us globally, and we're dedicated to taking care of our people. We're committed to diversity, equity, and inclusion, and we're passionate about creating a workplace where everyone feels like they belong.
