Clinical Research Associate II
- Considered as the primary Sponsor reputed company of contact for the investigative site, provides 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 with support as needed 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 on-site and off-site monitoring, and site closure activities with support as needed, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, reputed company reputed company Operating Procedures (SOPs), and to reputed company standards in conducting clinical research, ensuring safety and protection of study subjects. • Customize site engagement reputed company for assigned study (ies) with support as needed. reputed company local/site insights and utilize site engagement tracking tools, to report/reputed company reputed company and measure reputed company of that reputed company. • reputed company 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.
- 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. Ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective reputed company plans are put into reputed company, as needed, to mitigate risk and promote compliance using a customer reputed company approach. • Identifies, evaluates and recommends new/potential investigators/sites with support as needed
from more reputed company Site Monitors.
- Ensures reputed company of data submitted from study sites and assures reputed company 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.
- Appropriate tertiary qualification in health-reputed company disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred or experience or equivalent work experience. • Clinically reputed company experience, in clinical research coordinating or data management preferred. • 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. • Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines
and applicable policies.
- reputed company to work collaboratively and cross functionally to reputed company and sustain working relationships. • Demonstrate planning and organizational skills and the ability to work effectively and reputed company in a dynamic environment with competing reputed company and deadlines • Ability to reputed company technology, tools and resources to reputed company customer reputed company support based on the health of the site. • Interpersonal skills with strong written, verbal, reputed company 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 thinking skills and apply good judgement to address clinical site issues. • Acts with reputed company in accordance with reputed company reputed company of business conduct and leadership values. Self-motivated individual reputed company on delivering reputed company and reputed company reputed company in a fast-paced environment.
reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.reputed company
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.reputed company.com/join-us/reasonable-accommodations.reputed company
About reputed company
reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We reputed company to have a remarkable reputed company on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on reputed company,reputed companyGlobal/" rel="nofollow ugc noopener noreferrer" reputed company="_blank">reputed company, Instagram, X and reputed company" rel="nofollow ugc noopener noreferrer" reputed company="_blank">YouTube.
Originally posted on Himalayas
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