Job Description
Job Description Clinical Research Associate-
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.
They should have prior experience in Clinical Research or Clinical Trials and a solid understanding of related processes.
This role requires someone who is a quick thinker, adaptable to evolving workflows, and proactive in seeking clarification when needed.
This role requires a resourceful and agile individual who can 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.
The ideal candidate 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.
Education Bachelors degree-Major/Field of Study- Biology, Health Sciences, Mathematics, Computer Science, or equivalent
Licenses and Certifications
None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have but not required.
Pay ranges between $42-49/hr based on experience
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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