Career Opportunities
Assistant Director of Clinical Monitoring Services
This is a highly responsible and professional position. The Assistant Director of Clinical Monitoring Services (Assistant DCM) will work with a sponsoring company or CRO in the monitoring of a pharmaceutical, device, or biologics trial with an emphasis placed on ensuring the highest ethical and clinical standards.
The primary focus of the Assistant DCM will be to supervise monitoring activity, working closely with the Director of Clinical Monitoring Services. This position requires travel up to 60% of the time.
Knowledge, Skills, and Abilities
- RN or BA/BS degree in a health-related field (Master’s in appropriate field, in absence of clinical experience)
Experience:
- Minimum 60 months clinical research experience
- Minimum 36 months CRA experience
- Clinical research certification (CCRA or equivalent)
- Demonstrated proficiency as a Lead CRA
- Capable of working in a global study environment
- Strong working knowledge of US federal regulations related to clinical research studies, ICH Guidelines, ISO 14155 and GCP.
- Excellent organizational and communication skills.
- Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of the internet.
- Time management skills and problem solving abilities.
- Ability to work independently and with team.
- Ability to acquire knowledge of investigational products and different therapeutic areas of study.
- Ability to resolve and make judgments regarding administrative and/or clinical problems with minimal supervision.
- Supervise CRAs to ensure duties are carried out as assigned. For some projects, this may include supervising third party vendors.
- Complete CRA evaluation monitoring visits.
- Prepare and deliver bi-annual performance evaluations for internal CRAs.
- Evaluate new projects and make CRA assignments.
- Participate in the periodic review and revision of departmental policies and SOPs to ensure compliance with corporate policies, FDA regulations, and other applicable regulations.
- Participate in the selection process of new hires, including reviewing candidates’ credentials, interviewing candidates, and making hiring recommendations.
- Maintain professional skills by keeping abreast of literature, attending conferences, courses and meetings.
- Maintain knowledge of regulations, guidelines, policies, and practices for conducting (global/international) clinical trials.
- Work with internal teams to kick-off new projects that involve monitoring.
- Assist with sales calls.
Salary commensurate with experience.
If you're interested in a career with IMARC, please send your resume to [email protected].