Contract Senior Clinical Research Associate
vor 7 Monaten
**POSITION TITLE**: Senior Clinical Research Associate
**DEPARTMENT**:Ora Europe
**LOCATION**: Remote, Germany
**Ora Values the Daily Practice of **
- Prioritizing Kindness
- Operational Excellence
- Cultivating Joy
- Scientific Rigor_
At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects.** **Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.
**The Role**:
Ora's Senior Clinical Research Associate (Sr. CRA) develop strong clinical site relationships and are accountable for performance and compliance for assigned protocols at our sites. Our Sr. CRA's will work with the oversight of the Lead CRA and Line Manager. As a Sr. CRA, you will ensure Ora's compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora's policies, and Sponsor SOPs by partnering cross functionally with Ora's Quality Assurance and Regulatory teams, (any other internal groups they partner with?) and developing relationships with sponsors and sites through all phases of the trial. To be successful, you will need to obtain a deep understanding of various study protocols and be prepared to provide input on site selection and validation activities. After completing all required training, Ora Sr. CRA's will support the site contact and site managers, act as the primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.
**What You'll Do**:
- Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gain in-depth understanding of the study protocol and related procedures.
- Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
- Participate & provide input on site selection and validation activities.
- Perform remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased
- Subjects' right, safety and well-being are protected
- Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
- Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Supports audit/inspection activities as needed.
- Travel Requirements up to 75%.
- Adhere to all aspects of Ora's quality system.
- Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora's values
- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
- Responsibilities may differ from the above based on the specific needs of the business.
**What We Look For**:
- _Experience needed for the Role: _
- Bachelor's degree with 3 years' experience as a Clinical Research Associate or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education.
- _Additional Skills & Attributes:_
- Ophthalmic experience strongly preferred.
- Capacity to routinely assess protocol and GCP compliance.
- Ability to understand how to properly assess an investigative sites' capabilities to conducting clinical research.
- Demonstrated ability to verify source data to reported data.
- Ability to monitor and report on the progress of the trial from start-up to completion.
- Knowledge of how to select and qualify an investigative site
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