Clinical Research Associate - Onsite

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This position will include monitoring and oversight of clinical sites to ensure timely and successful execution of clinical studies, resolving study-related discrepancies.
This position will ensure compliance with protocol and all regulatory policies, procedures, and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
Also, will ensure validity of study by identifying/resolving discrepancies and obtaining missing data and may track more routine aspects of a study. of clinical documents, which may include protocols, case report forms (CRFs), memos, correspondence, reports, and other required documents. Also, conduct new CRA orientation, onboarding, and training activities.

Candidate will proactively identify, and address issues related to study monitoring and clinical site management.
Track and communicate monitoring and site management updates and issues; escalate monitoring-related study timeline and quality risks to the Clinical leadership.
Maintain clinical operations processes, new employee onboarding, internal protocol training, monitoring tracking tools and study tools/templates for CRAs and site personnel.
Manage CROs/vendors for outsourced activities as applicable, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, project master files, and data management).
Ensure adherence to Good Clinical Practices, Industry standards, standard operating procedures and to all other regulatory and quality standards in conducting Lingo Clinical research and development.
Operate under minimal supervision and demonstrate a high degree of proficiency.
Undertake additional projects and tasks as determined by department and organizational needs.
The successful candidate will demonstrate the ability to work collaboratively across cross-functional teams, including Quality, Compliance, Product Development, and Engineering, etc.

Bachelors degree-Major/Field of Study- Biology, Health Sciences, Mathematics, Computer Science, or equivalent
Prior experience in Clinical Research or Clinical Trials and a solid understanding of related processes.
Quick thinker, adaptable to evolving workflows, and proactive in seeking clarification when needed.
Think critically, adapt to evolving workflows, and proactively seek clarification when needed. The ideal candidate will also demonstrate creativity in problem-solving and be open to exploring innovative ideas and process improvements.
Must be able to quickly learn internal processes and demonstrate the ability to work independently with minimal supervision.
While support is always available, this role requires someone who can take initiative and adapt quickly in a fast-paced environment.

Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.
Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
Working knowledge of GCP, Clinical and Regulatory Affairs.
Flexibility in daily activities.
Proficient with MS Office Suite.

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