What are the responsibilities and job description for the In-House Clinical Research Associate position at Associated Medical Professionals?
The in-house Clinical Research Associate (CRA I) supports our ever-growing Clinical Research platform at U.S. Urology Partners. As an important member of the team, the CRA-I will spend time monitoring each of the various Clinical Research sites at U.S. Urology Partners based on the monitoring plan. The position will report to the Vice President of Research and support quality assurance as it relates to respective sites. The In-House Clinical Research Associate partners with the Vice President of Research to ensure alignment of activities with study projects and timelines to include, but not limited to, essential document collection and review; FDA/GCP/ICH and regulatory compliance; data management and query resolution; document and SOP review; study document/plan development and review; maintenance and close-out of in-house site management activities; and clinical operations support activities and tasks.
Essential duties and Responsibilities
To perform this job successfully, an individual must be able to perform the following activities:
To perform this job successfully, an individual must be able to perform the following activities:
- Requires 65% travel
- Performs an array of assigned duties including essential document collection and review; ICF review; study document/plan development and review; maintenance and close-out of in-house site management activities in accordance with the protocol; review and compliance with standard operating procedures (SOPs); ICH/GCP guidelines and all applicable regulatory requirements
- Will provide monitoring reports to the Vice President of Research
- Obtain, review (to ensure completeness, accuracy, and regulatory compliance), and process essential regulatory, and administrative documents, and Informed Consent Forms (ICFs)
- Travels to all U.S. Urology partner sites to review to monitor charts according to our SOP
- Ongoing interaction with clinical operations team members and Investigator site staff to obtain and relay key study issues, status updates, and other study information to the Vice President of Research
- Participate in the review and development of source documents and CRF guidelines
- Performs in-house review of CRF data for completeness and accuracy, and resolves data management/query issues with study sites and vendors as needed
- Reviews data to identify protocol deviations and risks to subject safety/data integrity
- Evaluates the execution of the study protocol at the site level. Uses judgment and experience to evaluate the overall performance of site and site staff and immediately communicates/escalate serious issues to the Vice President of Research
- Reports any non-compliance directly to the Vice President of Research
- Follows SOPs and the Clinical Monitoring Plan
- Supports and monitors clinical trials to ensure investigator obligations are met and in compliance with the currently approved protocol/amendment(s); applicable study procedures; applicable federal and local regulatory requirements; GCP; and company policy and procedures
- Supports the oversight of all activities listed and ensures all duties/documents/protocols/etc. meet our expectations, and delivers them in accordance with the sponsor’s expectations, trial protocol, ICH/GCP guidelines, and applicable SOPs (local/US/international)
- Verifies that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents
- Performs other work-related duties as assigned or required
What We are Offer You
At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters”
Compassion
Make Someone’s Day
Collaboration
Achieve Possibilities Together
Respect
Treat people with dignity
Accountability
Do the right thing
Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more.
About US Urology Partners
U.S. Urology Partners is one of the nation’s largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery. U.S. Urology Partners was formed to support urology practices through an experienced team of healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy.
Salary Range: Please note that the hourly range for this position will vary based on experience level, education and geographical location.
$0.00 - $0.00 / hour
U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.
