The Clinical Trial Specialist is responsible for supporting the day-to-day implementation and operation of clinical study execution, monitoring activities, and other clinical trial support activities according to Standard Operating Procedures, International Council for Harmonization Good Clinical Practice (ICH-GCP) guidelines, and other applicable regulations.
The Clinical Trial Specialist is accountable for the execution of the study start-up strategy and planning and ongoing maintenance of a clinical trials, including the management and coordination of start-up activities such as alignment with country regulations, site document collection and approval, Informed Consent Form (ICF) customization, and trial master file (TMF) set-up and maintenance, as required per trial type.
Collaborates and liaises with interdepartmental team members (regulatory, contacts, clinical) to enable a rapid clinical trial start-up.
May provide a role in the coordination or collection of feasibility questionnaires for a study. Works with USRC Research Leadership to obtain approval of the study-specific feasibility questionnaire, as needed.
May distribute Confidential Disclosure Agreements (CDAs) and feasibility questionnaires to sites and follows up with sites accordingly to assess interest and ability.
Sends regulatory packets to selected sites and documents/follows-up with sites on the start-up process.
Distributes and tracks protocol amendments and IRB/ethics approvals of the amendments, as required.
Supports sites by providing answers to questions required for IRB/ethics committee submissions.
Supports sites in the resolution of central IRB issues; assists with obtaining final review and approval.
Supports the Director of Regulatory Affairs in liaising with central IRBs, as applicable.
Provides central support to study sites to ensure their regulatory binder is maintained in compliance with GCP standards and sponsor regulations.
Assists with the customization and review of site-specific Informed Consent Forms (ICFs); follows-up with sites as needed.
Coordinates document translations required for IRB/ethics committee review/approval.
Notifies the Director of Regulatory Affairs when initial essential documents are available for review. Works with the Director of Regulatory Affairs to resolve any concerns.
Contributes to the development of site-specific timelines for site initiation visits.
Assists with set-up, routine maintenance, Quality Control (QC), and final completion of the electronic and/or paper TMF (as required per trial type).
Maintains up-to-date and accurate tracking of the start-up status for each site in the applicable system(s) for the study.
U.S. Renal Care is an Equal Opportunity Employer/Disabled/Veteran.
Bachelor’s degree in related field required.
Eighteen (18) plus months of relevant experience required.
Demonstrated proficiency in project management including planning, execution, delivery, and reporting.
Demonstration of proactive problem-solving skills.
Good knowledge of clinical research process related to study start-up and medical terminology.
An understanding of regulatory and central/local IRB submission processes.
Ability to manage multiple competing priorities.
Working knowledge of current ICH GCP guidelines and applicable regulations.
Advanced analytical skills required.
Valid driver’s license in applicable state. License must be maintained as current, without restrictions and good driving record.
Proficient computer skills, including Microsoft Office (Word and Outlook); proficiency in required USRC applications within 90 days of hire.
About U.S. Renal Care
Our Mission at U.S. Renal Care is simple: “To be the highest quality provider available to patients with chronic and acute renal disease. We accomplish this mission by partnering with the best Nephrologists in the country, by providing the best trained professional staff in our centers, by demonstrating ultimate customer service, by offering state of the art technology and by constantly educating patients and family about the disease process. The result is excellent patient outcomes and the best service available.”
U.S. Renal Care stands out above other providers by:
Patients are our focus, and we do our best to provide compassionate care, where and when patients need it.
Partnering with leading physicians
We work with quality physicians, who provide quality care to patients and also lead our facilities through joint venture partnerships.
Making diversity & inclusion part of our DNA
We take a comprehensive approach to diversity & inclusion so that our vibrant mix of providers, clinic staff and corporate employees represent our equally diverse and extraordinary patients. This is important because an inclusive culture supports a better work environme...nt for our employees, better care, and ultimately better outcomes for our patients.
Committing to the communities we call home
In each of our locations, we work closely with elected leaders, nearby hospitals, physicians and advocacy groups.
Providing highly-trained professional staff
We offer an experienced team of nurses, social workers and dietitians, acknowledging that quality care requires a quality team working in conjunction with a highly-qualified program.
Offering state-of-the-art technology
Every piece of equipment is top-of-the-line – from the at-home and in-center dialysis machines down to the therapeutic chairs in our facilities.
Delivering care in a healing environment
We design our centers with patients’ healing and comfort in mind, promoting a relaxing experience in a soothing environment.
Educating patients and family
We work with patients and their families to help them understand their disease and their therapeutic options. This is critically important in order for them to maximize the benefits of therapy.