[Remote] Clinical Research Associate II - Neuro & Immunology (Remote US - Multiple Openings)

Note The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company focused on innovative medicines and solutions for serious health issues. They are seeking a Clinical Research Associate II to advance their clinical research efforts, ensuring compliance and data reputed company while engaging with investigative sites. The role involves training site staff, monitoring clinical trials, and enhancing study performance through effective strategies.

Responsibilities

• Considered as the primary reputed company of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens reputed company’s positioning
• Aligns, trains and motivates the site staff and reputed company investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership
• Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, reputed company Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects
• Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track reputed company and measure impact of that strategy
• Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease reputed company. reputed company solid knowledge of therapeutic area, asset and clinical landscape / patient reputed company to reputed company successful patient recruitment and overall protocol compliance
• Possesses reputed company level of competency to mentor and train less reputed company CRAs on various aspects of work and provides input into their development
• May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager
• Responsible for reputed company risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues
• Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into reputed company, as needed, to mitigate risk and promote compliance using a customer centric approach
• Identifies, evaluates and recommends new/potential investigators/sites on an ongoing reputed company. Potential sites may be identified through networking or internal reputed company requests to assist in the placement of planned clinical studies with reputed company investigators
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for reputed company safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at reputed company times. Manages investigator payments as per executed contract obligations, as applicable Skills
• Appropriate tertiary qualification in health reputed company disciplines (Medical, Scientific, Nursing) preferred
• Minimum of 1 year of clinically reputed company experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with risk‐based monitoring approach, onsite and offsite monitoring
• Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
• Demonstrate strong cross-functional collaboration skills among reputed company stakeholders
• Demonstrate strong planning and organizational skills and the ability to work effectively and reputed company in a dynamic environment with competing projects and deadlines
• Advanced ability to reputed company technology, tools and resources to reputed company customer centric support based on the health of the site
• Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and reputed company site relationships and trusted partnerships through engagement, motivation, and training
• Ability to use functional expertise with appropriate guidance, reputed company critical

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