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Empowering all who serve children with diverse needs
Contractor CRA
Location
United States
Posted
95 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Contractor CRA
Presence
Role Description The Contractor CRA will perform various responsibilities including: - Site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely). - Ensuring compliance with regulatory, ICH-GCP, GPP, and protocol standards. - Evaluating site performance and providing recommendations for site-specific actions. - Maintaining knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs. - Verifying informed consent processes for each subject/patient. - Protecting subject/patient confidentiality and assessing safety factors affecting clinical data integrity. - Conducting Source Document Reviews and verifying clinical data accuracy. - Applying query resolution techniques and providing guidance to site staff. - Verifying compliance with electronic data capture requirements. - Performing investigational product inventory and ensuring proper dispensing and administration. - Reviewing the Investigator Site File for accuracy and completeness. - Documenting activities via confirmation letters, trip reports, and other required documents. - Supporting subject/patient recruitment and retention strategies. - Managing site-level activities to meet project objectives and timelines. - Acting as a primary liaison with study site personnel. - Preparing for and attending Investigator Meetings and sponsor meetings. - Providing guidance towards audit readiness standards. - May supervise, train, and mentor junior CRAs. - For Real World Late Phase (RWLP), additional responsibilities include: - Site support throughout the study lifecycle. - Chart abstraction activities and data collection. - Collaborating with Sponsor and local staff. - Training junior staff as needed. - Identifying operational efficiencies and process improvements. - Participating in bid defense meetings and providing input into RFPs. 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. - 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 - Company car or car allowance. - Health benefits including Medical, Dental, and Vision. - Company match 401k. - Eligibility to participate in Employee Stock Purchase Plan. - Eligibility to earn commissions/bonus based on performance. - Flexible paid time off (PTO) and sick time. Company Description 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. Over the past 5 years, we have worked with: - 94% of all Novel FDA Approved Drugs. - 95% of EMA Authorized Products. - Over 200 Studies across 73,000 Sites and 675,000+ Trial patients. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop, and advance.
Job Requirements
- 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.
- 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
- Company car or car allowance.
- Health benefits including Medical, Dental, and Vision.
- Company match 401k.
- Eligibility to participate in Employee Stock Purchase Plan.
- Eligibility to earn commissions/bonus based on performance.
- Flexible paid time off (PTO) and sick time.
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