Sr. Clinical Research Associate

Arthrosi Therapeutics is a clinical stage company that is looking to expand their Clinical Operations Team. The full-time Senior Clinical Research Associate will be an integral member of the Clinical Operations team whose work drives the company to meet critical milestones in the Arthrosi clinical development programs. The successful candidate will be self-motivated, comfortable working in a start-up environment where everyone pitches in to realize company goals, flexible, and innovative.

Must have experience managing sites in late stage clinical trials, knowledge of clinical operations, ICH/GCP and FDA regulatory requirements.

Travel Requirements: Travel can range from 75% to 100%

Responsibilities:

• Ensure compliance with study protocol and regulatory and ICH GCP obligations in              assigned aspects of clinical site monitoring, such as site initiation, routine monitoring, CRA oversight visits, maintenance of study files, study close out, and retrieval of study materials
• Support the sponsor and CRO study team in meeting study milestones (site activations, database lock, Investigator Meetings, etc.)
• Support centralized monitoring activities between on-site visits to ensure timely resolution of action items, oversight of study data quality and flow, and proactively identify and mitigate/manage study risks and issues
• CRA will work closely with a cross-functional team in a fast-paced high growth environment to ensure that clinical trials are conducted on time and within budget, and in accordance with applicable GCP/ICH guidelines, other regulatory requirements, and Arthrosi SOPs.
• Partner efficiently, effectively, and professionally with participating study sites and vendors to ensure smooth study conduct.
• Provide study and/or site specific progress updates to Clinical Operations Leads and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
• Provide oversight support in the timely recruitment of trial participants with subsequent efficient and effective data management.
• Provide monitoring oversight through review of monitoring schedules, metrics, and reports.
• Participate and support the study team and Investigator sites in audit preparation and follow-up activities, as needed
• Support the development of study documents and tools, including study logs, manuals, templates, newsletters, and other documents, as needed.
• Recommend and implement innovative processes to improve and impact clinical trial management and deliverables including contingency plans.
• Coordinate and conduct data reviews and data cleaning activities.
• Tracking of ancillary and investigational supplies, specimens and/or imaging.
• Ensure compliance with ICH/GCP and global regulatory guidelines.
• Must be willing to travel within the United States and internationally (as needed).

Qualifications:

• Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
• Minimum of 4-6 years of clinical trial experience including vendor management experience (e.g., imaging, central lab, IRT) and clinical monitoring in pharmaceutical, biotech or CRO setting.
• Experience in late stage clinical trials, including global experience.
  
• Experience working in small/emerging biotech is ideal
• Willingness to be a “team player” and take on additional responsibilities as requested
• Thorough knowledge of drug development, clinical operations processes and procedures according to ICH/GCP and other regulatory guidelines.
• Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
• Able to recognize need(s), find solutions, and take initiative to address in pro-active manner.
• Strong organizational, time management, skills.
• Excellent communication skills, both oral and written.
• Strong collaborator with demonstrated record of success in a cross-functional team and fast- moving environment.

Arthrosi Therapeutics is an equal opportunity employer. All applicants will be considered for
employment without attention to the following: race, color, sex, sexual orientation, gender,
gender identity, religion, national origin, citizenship and/or immigration status, pregnancy,
genetic information including family medical history, physical or mental disability, child or
spousal support withholding, military or veteran status, medical condition, marital status,
AIDS/HIV, natural hair styles, political activities or affiliations, domestic violence, assault, or
stalking victim status, application for or enrollment in Medi-Cal, lawful conduct occurring
during nonworking hours away from the employer’s premises, credit report or credit
information, prior non-conviction arrest record, and any other protected class, in accordance
with applicable federal, state, and local laws.

Salary : $95 - $130