RESPONSIBILITIES
- Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit)
- Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, organization internal SOPs, and US and OUS regulations
- Create and implement a risk-based monitoring plan to work in conjunction with the existing monitoring plan
- Investigate discrepancies and participate in the development of processes to minimize possibility of recurrence during study conduct and closeout
- Participate in site initiation visits; train site personnel on sponsor and regulatory requirements for study conduct; participate in and/or conduct site meetings and prepare site initiation visit reports and associated documentation.
- Participate in site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with study
- Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded.
- Validate investigational device accountability by tracking the history of investigational devices from the organization to the field sites and through final disposition.
- Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Clinical Operations (e.g. Contracts), and recommend and develop process improvements.
- Contribute with development and delivery of trainings; GCPs, protocols, and database, compliance, device accountability, and adverse event reporting.
- Edit/amend informed consent documents.
EXPERIENCE & EDUCATION
- Bachelor's Degree or equivalent in Life Sciences or related field with 1 year previous field monitoring experience required or 3 years equivalent learning in a working environment with hands-on clinical research experience encompassing all aspects of the clinical process, including 1) Cardiovascular device trials; and 2) Cath lab, operating room and/or intensive care unit familiarity required
- Excellent written and verbal communication, presentation, interpersonal, and analytical skills required
- Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
- Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
- Good computer skills in MS Office Suite, including Word, Excel, Adobe
- Experience with electronic data capture preferred
- Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) preferred
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
