Chase Medical Research, LLC Hiring for Regulatory and Administrative Specialist Job at Waterbury, CT Full Time

GENERAL SUMMARY of POSITION:

Chase Medical Research has a newly added position in its Waterbury location for a Regulatory and Administrative Specialist. Duties of this specialist are multi-faceted and requires efficiency in business and database softwares, including but not limited to, MS Office 365 (Word, Excel, Teams, Sharepoint, Powerpoint), Xero Accounting, Adobe PDF, and HubSpot CRM. The individual will be responsible for clincial trial regulatory activities (50% of position’s time) and administrative responsibilities, including but not limited to human resource functions, accounting, data management and reporting activities.

The regulatory responsibilities entail the start-up, maintenance and close out phases of our clinical trials including, but not limited to, the preparation of documentation for regulatory submission to Sponsor/CRO/IRB and ensuring that all aspects of the submission are accurate and complete.

The individual will be using Chase Medical Research’s enterprise software (Hubspot, CRIO, Paychex and Xero) at an expanding rate as the knowledge base of the individual increases. Maintaining data integrity within the databases will be paramount.

The individual will be dealing with clinical and administrative professionals within CMR and at the Sponsor/CRO/IRB.

Although the work location is in Waterbury, there will be occassional travel to Hamden, CT location for regulatory purposes (e.g. archiving, signatures).

SUPERVISORS: Chief Financial Officer and Manager of Regulatory

WORKS WITH THE FOLLOWING:

CFO, CEO, Medical Director, Principal Investigators & Physicians, Director of Clinical Operations, Manager of Business Development, Patient Recruitment Specialists, Marketing and Regulatory Manager, Sponsor/CRO representatives, Clinical Research Team Members

Work using good clinical practices in the conduct of clinical investigations and maintains compliance with protocol and regulatory requirements. Also maintains compliance with any state, local and OSHA guidelines and regulations. Also, uses precaution to assure human subject protection.

POSITION REQUIREMENTS:

Knowledge, Skills, and Abilities: Knowledge of Customer Relationship Management (CRM). Relevant work experience in accounting, human resources, and office administration. Proficiency in computer applications, such as Office.com/Office 365, Proficiency in relevant computer applications.

Skill in establishing and maintaining effective working relationships with other employees, pharmaceutical organizations, and the public.

Education: Prefer Bachelor Degree. Experience may be considered in lieu of Bachelor Degree. Prefer education in business admin, human resources and/or accounting.

Experience: Prefer experience in clinical research’s regulatory environment.

Job Type: Full-time

Pay: $20.00 – $25.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Overtime

COVID-19 considerations:
WE ARE REQUIRING VACCINATION FOR COVID and FLU.

Education:

• Associate (Required)

Experience:

• Paychex: 1 year (Preferred)
• Accounting: 1 year (Preferred)
• Microsoft Excel: 2 years (Preferred)

Work Location: One location