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Syneos Health

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.

Senior Clinical Research Associate II

Research AnalystResearch AnalystFull TimeRemoteSeniorTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Poland

Posted

5 days ago

Salary

0

Seniority

Senior

No structured requirement data.

Job Description

Senior Clinical Research Associate II

Syneos Health

Role Description The Sr. CRA II will perform the following responsibilities: - Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely) ensuring compliance with regulatory, ICH-GCP, GPP, and protocol standards. - Evaluate overall site performance and provide recommendations for site-specific actions, communicating serious issues to the project team. - Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs. - Verify informed consent processes for each subject/patient. - Protect confidentiality of subjects/patients and assess factors affecting safety and data integrity. - Conduct Source Document Review and verify clinical data accuracy and completeness. - Apply query resolution techniques and guide site staff as necessary. - Utilize hardware and software for effective clinical study data review and capture. - Perform investigational product (IP) inventory and ensure compliance with protocols. - Review the Investigator Site File (ISF) for accuracy and completeness. - Document activities as per SOPs and Clinical Monitoring Plan/Site Management Plan. - Support subject/patient recruitment, retention, and awareness strategies. - Understand project scope, budgets, and timelines, managing site-level activities to meet objectives. - Act as primary liaison with study site personnel, ensuring compliance with requirements. - Prepare for and attend Investigator Meetings and sponsor meetings. - Provide guidance towards audit readiness standards and support audit preparations. - May supervise, train, and mentor junior CRAs. - For Real World Late Phase (RWLP), responsibilities include: - Site support throughout the study lifecycle. - Chart abstraction activities and data collection. - Collaborate with Sponsor and local staff. - Train junior staff as requested. - Identify and communicate out of scope activities. - Propose potential sites based on local knowledge. - Identify operational efficiencies and process improvements. - Develop informed consent forms. - Collaborate with RWLP Regulatory team. - Participate in bid defense meetings and provide input into RFPs. - 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. - Demonstrated good computer skills and ability 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 - Career development and progression opportunities. - Supportive and engaged line management. - Technical and therapeutic area training. - Peer recognition and total rewards program. - Inclusive culture where you can authentically be yourself.

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