POSITION SUMMARY:
Conduct monitoring visits at assigned sites for
protocols that are complex and/or require knowledge in advanced
therapeutic areas. Ensure that
clinical research studies are conducted in accordance with the protocol, standard operating procedures, good
clinical practice, and applicable regulatory requirements
RESPONSIBILITIES
Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good
clinical practice.
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
Administer protocol and related study training to assigned sites and
establish regular lines of communication with sites to manage ongoing
project expectations and issues.
Evaluate the quality and
integrity of study site practices related to the proper conduct of the
protocol and adherence to applicable regulations. Escalate quality
issues to
Clinical Project Manager (CPM),
Clinical Research Specialist CRS) and/or line manager.
Manage the progress of assigned studies by tracking regulatory
submissions and approvals, recruitment and enrollment, case report form
(CRF) completion and submission, and data query generation and
resolution.
Create and maintain appropriate documentation
regarding site management, monitoring visit findings and action plans by
submitting regular visit reports, generating follow-up letters and
other required study documentation.
Act as a mentor for
clinical staff including conducting co-monitoring and training visits.
May provide assistance to the
Clinical Project Manager and/or CRS with design of study tools, documents and processes.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Strong knowledge of, and skill in applying, applicable
clinical research regulatory requirements; i.e., Good
Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Strong therapeutic and protocol knowledge as provided in company training
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
Strong written and verbal communication skills including good command of English language
Strong organizational and problem-solving skills
Effective time management skills
Ability to manage competing priorities
Good mentoring and training skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a health care or other scientific discipline or
educational equivalent and 2 5 years of on-site monitoring experience;
or equivalent combination of education, training and experience.
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