Senior Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Establish and nurture robust relationships with sites, ensuring continuity throughout all stages of the trial.

• Conduct clinical study site management and monitoring activities under supervision, adhering to ICH-GCP, Sponsor SOPs, local laws and regulations, the study protocol, Site Monitoring Plan, and related documents.

• Acquire a thorough understanding of the study protocol and associated procedures.

• Coordinate and manage multiple tasks in collaboration with other internal teams to ensure Site Readiness.

• Engage in and contribute to site selection and validation processes.

• Execute both remote and on-site monitoring and oversight activities using various tools to ensure:

• Data collected at the site is complete, accurate, and unbiased.

• The rights, safety, and well-being of subjects are safeguarded.

• Undertake site visits, including evaluation, initiation, monitoring, and close-out visits, ensuring that clear, comprehensive, and accurate visit and non-visit contact reports are recorded in a timely manner.

• Gather, review, and oversee required regulatory documentation for study start-up, maintenance, and close-out.

• Communicate effectively with Investigators and site staff regarding issues related to protocol implementation, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.

• Identify, evaluate, and resolve site performance, quality, or compliance issues and escalate them as necessary in collaboration with the Clinical Research Lead and CRA line manager.

• Manage and maintain information and documentation in CTMS, eTMF, and various other systems as required and within designated timelines.

• Assist with audit and inspection activities as necessary.

• Willingness to travel up to 75%.

⛳️ Requirements

• Bachelor's degree accompanied by 3 years of experience as a Clinical Research Associate, or an equivalent combination of education, training, and experience. Experience may substitute for education.

• Preference for candidates with ophthalmic experience.

• Ability to routinely assess compliance with protocols and GCP standards.

• Proficiency in evaluating an investigative site's capacity to conduct clinical research effectively.

• Proven capability to verify the accuracy of source data against reported data.

• Skill in monitoring and reporting the progress of the trial from start to finish.

• Understanding of the criteria for selecting and qualifying investigative sites.

• Strong attention to detail to ensure the completeness of the investigator site file, along with knowledge for reconciling and managing test articles during initiation, interim, and close-out visits.

• Advanced understanding of federal regulations governing research and the standards defining Good Clinical Practices (GCPs).

• Capability to read and comprehend a clinical research protocol and recognize the importance of adhering to it.

• Proficient in Excel, CTMS, and EDC systems.

• Multilingual abilities are a plus.

🏝️ Benefits

• Comprehensive healthcare options including Medical, Dental, and Vision starting on day one.

• Flexibility to take time off to relax and recharge, in addition to 14 company-paid holidays.

• Competitive salaries supplemented by a 401K plan through Fidelity with company matching.

• Support for adoption and fertility assistance, alongside 16 weeks of paid Parental Leave.

• Providing peace of mind to ensure you and your family feel secure.

• Reimbursements available to support your remote workspace and wellness purchases.

• New Directions is committed to assisting you and your family with any challenges you may encounter.

• Continuous opportunities for personal and professional growth in your career journey.

• Opportunities to collaborate with colleagues globally.

• A chance to contribute to research on new ophthalmic therapies that will impact patients worldwide.