PLACE OF PERFORMANCE: Richmond, VA
- Bachelor’s Degree in a scientific field and 2 years of monitoring experience; or equivalent combination of education, training, and experience.
- IDE-PMA (medical device) monitoring experience strongly preferred. (Absent device-specific monitoring experience, IND/NDA [pharma] experience a possibility to meet this requirement.)
- ACRP or SoCRA certification preferred.
- Good knowledge of applicable clinical research regulatory requirements, i.e., Code of Federal Regulations (CFR), Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and ISO 14155
- Proficiency in Microsoft Office Applications.
- Strong written and verbal communication skills
- Good organizational, interpersonal and problem-solving skills.
- Strong attention to detail.
- Time management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients and site personnel at assigned sites
DUTIES AND RESPONSIBILITIES:
- Perform site selection, start-up/regulatory, initiation, monitoring, and closeout visits using good clinical practices, applicable regulations, SOPs and work instructions.
- Provide protocol, Good Clinical Practice, and related study training to assigned sites.
- Establish and maintain regular lines of communication with sites to manage ongoing study expectations and potential issues.
- Supports study-level document submissions for IRB review/approval and supports Investigator-level IRB submission efforts.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the study and adherence to applicable regulations.
- Escalate quality issues to Clinical Research Coordinator.
- Collaborate with Field Clinical Specialist (FCS) to ensure the site has all necessary procedure support during the study enrollment period.
- Execute assigned work efficiently and adhere to project timelines.
- Manage the progress of assigned study sites by documenting regulatory submissions and approvals, recruitment and enrollment metrics, 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, essential document collection and filing, and other required study documentation.
DECISION MAKING/JUDGEMENT: This position involves projects and/or assignments requiring considerable decision-making authority regarding procedures, processes, plans, and schedules. Ability to work independently or in a team setting is necessary.
PHYSICAL DEMANDS/WORK ENVIRONMENT: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Needs ability to use a keyboard to enter and retrieve data.
- Must be able to lift 5-20 pounds.
- Remaining in a stationary position, often standing, or sitting for prolonged periods.
- Moving about to accomplish tasks or moving from one worksite to another.
- Local travel and CONUS/OCONUS may be required.
|Job Category||Health Care|