CRA Manager

CRA MANAGER

COMPANY INFO:

MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.  We specialize in the nationwide recruitment of clinical trials personnel.

 

Our client sets up and manages Phase I-IV clinical studies from study set up through NDA submission and is seeking to add a CRA Manager to their team. 

 

JOB SUMMARY:

The CRA Manager will manage, monitor, and oversee our Regional Monitors. A minimum of 5 years industry experience or 2 plus years monitoring.  This individual should be a hard worker and not afraid to get their hands dirty.  We prefer the Manager to work from our corporate office in New Jersey but are open to individuals working remotely.  The one stipulation is for the person to come into the office one time a month. 

 

RESPONSIBILITIES:

" Responsible and accountable for all study monitors across multiple clinical trials

" Define and manage project resource needs for site monitoring and establish contingency plans for key resources

" Develop and maintain SOPs related to field monitoring

" Promote effective teamwork; ensure that all monitors allocated to assigned projects adhere to professional standards and SOPs established for clinical research

" Provide in person performance evaluation of monitors; resolve conflicts as needed

" Initiate improvements to enhance the efficiency and the quality of the work

" Manage monitor time/expense and billable hours

" Present at investigator meetings and internal meetings as required

" Independently responsible for hiring, training and retaining a team of contract and permanent monitors

 

QUALIFICATIONS:

" Minimum 5 years experience in clinical research with at least 3 years as a field monitor and 2 years in a management role

" Understanding of drug development process over different phases and FDA regulations and ICH guidelines

" Excellent written and oral communication skills

" Strong relationship building skills with different partners

" Experience using clinical trial methodologies and technologies

" Experience managing teams across cultures and geographies

" Experience developing and delivering presentations

 

EDUCATION:

" Bachelor's degree in nursing, science or other medical field

 

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.