Sr Clinical Research Associate – Imperative Care – Campbell, CA

Job title: Sr Clinical Research Associate Company: Imperative Care Job description: SUMMARY: The Sr. Clinical Research Associate will play a key role to proactively monitor the conduct and progress of clinical studies to ensure compliance with the study protocol, standard operating procedures, good clinical practices, and applicable regulatory requirements. In addition, the candidate will lead the clinical site support throughout the lifecycle of the project and liaise with internal team members and external clinical sites, investigators, consultants and vendors involved in study execution. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

• Lead clinical research activities to ensure successful execution of clinical studies
• Demonstrate understanding of the therapeutic area of interest and the study protocol assigned
• Oversee the conduct of the clinical studies at participating clinical sites to ensure compliance to the protocol, standard procedures, good clinical practice, and regulatory requirements
• Contribute to review and development of protocol, informed consent form, case report forms, monitoring plans, and other study reports
• Manage site start-up activities and support participating sites with IRB/EC preparation and submission
• Perform clinical site qualification to ensure the staff, facilities and patient population can support the study
• Perform site initiation, monitoring and close out visits and conduct site training and re-training during the study
• Manage study sites to ensure enrollment is on track and data entry is timely, accurate and complete and manage CROs to ensure the study is conducted in compliance with the protocol, GCP and the regulatory requirements
• Conduct monitoring visits and co-monitoring visits to evaluate external CRA
• Identify, address, and resolve issues that arise with participating clinical sites.
• Maintain the trial master file Track study enrollment and provide regular updates to study team
• Create/coordinate creation of patient educational materials, advertisement, or other recruitment materials to support enrollment ramp-up efforts
• Collaborate with clinical team and cross functional teams and coordinate shipment, tracking and accountability of the investigational device
• Assist in project planning, study financial planning and responsible for invoice tracking/reconciliation, issuing payments and vendor management
• Prepare participating clinical sites for potential inspection

May be required to contribute to operational aspects of the clinical function including:

• Identify project sites, define budgets and time required to complete a clinical study concept
• Contribute to EDC and other clinical trial systems’ definition of database specifications and user acceptability testing
• Recruit investigators / study sites and negotiate support levels
• Ensure appropriate regulatory controls (site and patient) are in place for all study activities
• Manage clinical trial agreements and internal and external review process
• Review Regulatory documentation for completeness and accuracy during study initiation and maintain such documentation throughout the study
• Ensure site adherence to the study protocol, relevant SOPs, GCP/ICH guidelines, HIPAA, trial registration, and all other applicable regulatory guidelines
• Assist site personnel with data changes as needed to ensure clarity and accuracy of data

EDUCATION/EXPERIENCE:

• Bachelor’s degree in related field and 5+ years of experience in medical device industry and clinical research or advanced degrees (Master’s, MD or PhD) with 2 years of experience in a relate field or equivalent experience
• Experience in IDE studies strongly desired
• Extensive knowledge of FDA requirements, ICH GCP, other standards as well as medical terminology
• Extensive knowledge of hospital, and health care environments
• Must have high standards for quality of work
• Good analytical thinking and problem-solving skills
• Able to work independently and in a team environment
• Strong sense of urgency to meet timelines and project deliverables
• Excellent written and verbal communication skills required
• Experience interacting with physicians and research staff
• Must be willing to travel 20 - 30%
• Flexible, adaptable, and able to work under pressure and to meet tight timelines
• Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently
• Excellent interpersonal and negotiating skills; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with sensitive and confidential matters

Powered by JazzHR Expected salary: Location: Campbell, CA Job date: Wed, 14 Sep 2022 04:43:41 GMT Apply for the job now! Apply tot his job Apply To this Job