Assistant Clinical Operations Manager

SUMMARY: 

The Assistant Clinical Operations Manager will provide support to the day-to-day of the clinic as well as manage daily operational and administrative activities. This individual is responsible for the overall operational and budgetary success of the site clinic. Additionally, the Assistant Clinical Operations Manager will play an essential role in taking direction from the Site Operations Manager, ensuring that the clinic is delivering high quality results, and efficiently.

 ESSENTIAL DUTIES AND RESPONSIBILITIES 

1) Comply with all company policies, procedures and conduct. 

2) Strictly adhere to confidentiality and compliance standards. 

3) Build and engage clinic teams to promote teamwork and a cohesive environment. 

4) Implement productivity metrics for clinic personnel and departments. 

5) Work closely with the Clinical Operations Manager 

6) Ensure SOPs, policies and study protocols are enforced. 

7) Maintain & audit quality control of research studies, documentation and outcomes. 

8) Maintain & audit site regulatory files. 

9) Audit study e-source documentation to comply with study protocols. 

10) Collect A/E and SAE. 

11) Other tasks as assigned. 

QUALIFICATION REQUIREMENTS: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

EDUCATION and EXPERIENCE: 

1) Associate's degree in healthcare or equivalent experience, required. 

2) 3 years' experience in clinical research; required. 

3) 3 years' experience working as a Clinical Research Coordinator, required. 

4) 5 years' experience in managing teams, required. 

5) Proficient problem solving skills & conflict resolution. 

6) Comprehensive knowledge of FDA, GCP & confidentiality. 

7) Proficient in Microsoft Word, Excel and PDF. 

8) Excellent verbal and written communication skills. 

9) A proven ability to constantly prioritize multiple projects in a rapidly changing environment. 

10) Must be comfortable with a rapid-growth company. 

Language Skills 

Ability to read, analyze and interpret instructions, regulations, protocols, and procedures. Ability to write reports and correspondences. Ability to effectively present information and respond to questions from groups of managers, employees, physicians and patients. 

Mathematical Skills 

Ability to analyze figures and amounts such as laboratory test results, statistical data and employee timecard calculations. 

Reasoning Ability 

Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. 

Travel Required: 

Estimated 80% clinic work. Some travel may be required.