Sr. Clinical Research Associate
(Cell / Gene Therapy)


Job Number:    #0233


Location:      Montgomery County Maryland
Company:    Well established (the late 1990s) biopharmaceutical company

Focus:           Regenerative therapies - cell therapy
Misc:             There are eight key management employees listed at this company and we are responsible for the recruitment of three of them



Home based, remote with approximately 50% travel

POSITION SUMMARY                             
The Sr. Clinical Research Associate will be involved in all stages of the clinical study and will serve as the Lead CRA for active studies.  The Sr. CRA will be primarily responsible for oversight of all study activities including study management and monitoring.



Essential Duties & Responsibilities

  • Oversee investigative sites and study vendor selection including CRO and laboratories

  • Coordinate set up of investigative site budgets and agreements with Study Manager/CRO

  • Serve as the first point of contact for assigned external partners

  • Sign off on-site approval documentation

  • Support protocol, informed consent, and clinical study report writing efforts within the clinical development team

  • Establish and lead internal project team meetings

  • Review and sign-off on monitoring reports.

  • Conduct monitoring evaluation visits for CRO and internal monitors

  • Review EDC for data trends and provide feedback to CRO monitors

  • Review study data listings and collaborate with data management, statistics, and programming groups to ensure appropriate data collection, quality and analysis

  • Present trial status report to management

  • Perform monitoring visits independently as needed

  • Other tasks as assigned

Education & Experience

  • Bachelor’s degree in science or related field

  • At least 8 years of clinical research or related experience

  • At least 4 years of monitoring experience

  • Knowledge of 21CFR parts 312 (Investigational New Drug Application); 50 (Protection of Human Subjects) and 56 (Institutional Review Boards) and ICH E6 GCP

  • Computer skills which would include proficiency in Microsoft Office and Internet Explorer

  • Excellent written and verbal communication skills


Working conditions

  • Approximately 50% travel is required. 


Links to Other Job Descriptions 

VP of Regulatory Affairs
VP of Research & Development

Director/Sr. Director of Regulatory Affairs
Director/Sr. Director of Research & Development

Director of Clinical Program Management

Clinical Trials Coordinator






Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.


NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.


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