[Hiring] CRAII/Sr CRA @Syneos Health

Role Description

The CRAII/Sr CRA (Sponsor dedicated) is responsible for the following:

• Performs site qualification, site initiation, interim monitoring, site management, and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; communicates/escalates serious issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses 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.
• Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP).
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
• Applies query resolution techniques remotely and on-site, providing guidance to site staff as necessary.
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
• May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
• Documents 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.
• Supports subject/patient recruitment, retention, and awareness strategies.
• Understands project scope, budgets, and timelines for own and others’ activities in the clinical team.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
• Provides guidance at the site and project level towards audit readiness standards.
• May provide direct supervision, training, and/or mentorship to more junior level CRAs.
• For Real World Late Phase (RWLP), the Sr. CRA II will use the business card title of Sr. Site Management Associate II.
• Additional responsibilities include 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 (HCP) associations.
• 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.
• Participate in Case Report Form design and edit check development.

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.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation, and interpersonal skills.
• Moderate level of critical thinking skills expected.
• Ability to manage required travel of up to 75% on a regular basis.

Benefits

• 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.
• Commitment to building an inclusive culture.
• Opportunity to shape solutions that impact lives.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.