Clinical Research Associate (Monitor) **

Description

JOB SUMMARY: Independently perform routine and complex on site and in house site assessments for clinical trials research. Organize and prioritize time to complete concurrent assignments on multiple trials. Use critical thinking skills to monitor sites' compliance with study, sponsor, organizational, and government guidelines. Independently create new and customize existing templates to meet project needs. Collect, document, update, and report study information according to project specific scope of work and timelines. Critically assess trial processes, anticipate problems, and recommend improvements. Follow up, resolve, and report on complex issues identified during study monitoring and assessment activities.

DUTIES AND RESPONSIBILITIES:
1. Review routine and complex site activities through monitoring activities including on site visits and/or use of other media according to trial specific monitoring plan to assess study progress and protocol, regulatory and SOP compliance.
2. Document site management and clinical monitoring activities, site communication, and trial related activities.
3. Recommend revisions to improve efficiencies of monitoring tools, trial documents, and study processes. Develop and implement study specific versions.
4. Manage and review data and data systems, including case report form completion and submission, data query resolution, and overall data integrity according to established practices. Develop and implement improvements for data collection and data processing
5. Build and maintain effective working relationships with site personnel and internal and external study contacts.
6. Provide timely status reports to trial team members regarding site status, study issues and resolutions, and trial activities
7. Serve as subject expert for clinical monitoring activities and mentor subordinates, peers, and site personnel.
8. Other job duties as assigned.


Position Requirements
MINIMUM QUALIFICIATIONS:
1. 4-5 years clinical research experience including 3 years directly related CRA experience
2. Certified Clinical Research Associate or equivalent combination of education and experience
3. Strong knowledge of Good Clinical Practices regulations (FDA, ICH guidelines, ISO standards) and clinical research trial processes including site management
4. Expert clinical monitoring skills
5. Strong interpersonal skills, ability to establish and promote positive business relationships, customer service oriented.
6. Ability to write and speak clearly and concisely in a variety of communication settings and styles.
7. Ability to collaborate with study staff and internal and external partners to achieve goals
8. Excellent organizational skills and attention to detail
9. Ability to manage and direct several activities concurrently with competing goals and deadlines.
10. Ability to work independently with minimal supervision
11. Strong technical writing skills including spelling and grammar
12. Strong knowledge of science and medical terminology
13. Ability to travel 80% overnight, including consecutive nights
14. Proficiency with MS Office and clinical trial software

PREFERRED QUALIFICATIONS:
-Experience with medical device trials a plus
-Bachelors in clinical, health or life sciences preferred


Educational Requirements
Typically requires a 4-year degree in life sciences coupled with 4-5 years clinical research experience including 3 years directly related CRA experience

Full-Time/Part-Time
Full-Time

Shift
-not applicable-

Department
TMC - Regulatory Affairs