HCA, Hospital Corporation of America Clinical Research Associate II, Work From Home in Nashville, Tennessee
*Sarah Cannon Research Institute *(SCRI) is the research arm of HCA's global cancer enterprise, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.
We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.
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Summary of Key Responsibilities: Perform routine site monitoring visits, participate in site selection, site initiation, and study closure activities to ensure that the clinical trial is being conducted according to the approved protocol, amendments and in compliance with Good Clinical Practice (GCP), SCRI and/or Sponsor SOPs, and all applicable regulatory requirements
Duties and Responsibilities: Duties include but are not limited to: * Assist in the Investigator selection and qualification process * Assist in the development of patient recruitment strategy * Attendance at Investigator Meetings * Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company standard operating procedures, applicable regulatory requirements and defined quality and performance standards * Ensure site IRB approval is current and all IRB documentation is in order * Maintain site monitoring schedule and serve as the principal point of contact for investigational sites * Document and report on clinical study progress (i.e. patient recruitment and discuss potential opportunities and risks with respective Project Team members) * Ensure patient safety is maintained and informed consent procedures are carried out * Provide training and update investigative site team of any changes in study conduct and documentation requirements * Ensure continued acceptability of the investigator, clinical site team and facility * Review clinical data, source documentation, CRF, and investigative site regulatory files * Work closely with data management and site to resolve discrepancies * Ensure investigational product accountability accuracy and oversee investigational product inventory * Liaise with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies * Meet with clinical study sponsor representatives as requested * Submission of routine monitoring visit reports and follow-up letters as per required timelines. * Ensure resolution of issues with investigative sites * Attend meetings as assigned and report on actions * Participate in educational activities and programs * Maintain strictest confidentiality * Work closely and effectively with all other department personnel to ensure appropriate communication and study conduct * Assist other staff as requested and perform other related work as needed * Function as a mentor for team members * Maintain awareness of current developments in therapeutic area relative to assigned projects * Throughout the conduct of the clinical trial assesses adherence to SCRI SOPS, GCP and all applicable regulatory requirements * Travel is required. May also involve travel to meetings or attendance at conferences. Overnight stays may also be required. In addition, weekend and evening sessions may be required depending upon the workload and nature of current programs Mandatory: * Practices and adheres to the “Code of Conduct” philosophy and “Mission and Value Statement” * During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date. INDAF #LI-ND1
Competencies: * Knowledge:/A body of information needed to perform a tasks; May be obtained through education, training or experience / o Detail-oriented with knowledge of scientific, medical, and regulatory terms. o Knowledge of ICH Guidelines, GCP, and FDA regulations. o Understanding of the drug/device development process * Skills:/The proficiency to perform a certain task/ o Computer skills, including MS Word, Excel, Outlook, and PowerPoint; ability to learn new software if required o Professional writing and communication skills * Abilities:/An underlying, enduring trait useful for performing duties / o Ability to multi-task in fast paced environment is essential. o Ability to function in a team environment under time and resource pressures. o Ability to manage, organize, and make decisions. Education: Minimum Required: High School Diploma (GED) Preferred: Bachelor's College Degree (4 yr program)
Experience: Minimum Required: * Three years direct monitoring experience or equivalent; combination of monitoring experience with previous work in the clinical research industry may also be considered Preferred: * Three years direct oncology monitoring experience * Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and closeout)
Title: Clinical Research Associate II, Work From Home
Location: Tennessee-Nashville-Sarah Cannon Research Institute Clinical Operations
Requisition ID: 25319-3314