Study Coordinator

Sarah Cannon Research Institute (SCRI); Nashville (TN); Vor Ort; USD 55.000 - 90.000; Vollzeit

Zusammenfassung

Sarah Cannon Research Institute (SCRI) is seeking a Study Coordinator to plan and monitor complex Phase I-IV clinical trials. You will work closely with investigators, data operations, and sponsors to ensure protocol adherence and timely reporting.

Responsibilities include trial startup activities, patient eligibility verification, data entry, and monitoring for safety events according to regulatory guidelines. A Bachelor’s degree and clinical research experience are preferred.

Qualifikationen

• An understanding of clinical trial data.
• Knowledge of FDA guidelines and GCP is required.
• The ability to work independently in a fast paced environment.
• Interpersonal skills, detailed-oriented and meticulous.
• Computer skills with ability using clinical trial databases, electronic data capture, MS Access and Excel.
• Bachelor Degree is preferred.
• At least one year of experience in healthcare, research or other science related field.
• At least one year of experience planning and managing clinical trial process.

Aufgaben

• Lead the execution of trials for the research team.
• Plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out.
• Confirm patient eligibility and discuss discrepancies with nursing staff and physicians.
• Verify study procedures are performed within the protocol specified window.
• Participate in sponsor teleconferences to update on patients including research visits, toxicity, and overall response.
• Present in weekly protocol meetings to investigators, research staff, and management.
• Provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria.
• Update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments.
• Create study-specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable).

Kenntnisse

Clinical trial data

FDA guidelines

GCP knowledge

Independent worker

Interpersonal skills

Attention to detail

Trial databases

EDC software

Ausbildung

Bachelor degree

Tools

MS Access

Excel

EDC software

Jobbeschreibung

It’s More Than a Career, It’s a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

As the StudyCoordinator you will plan the execution andmonitorthe completion of complex Phase I-IV assigned clinical research protocols. Including abstracting,assemblingand organizing research data whilemonitoringadherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trialsponsorand study team.

• You will leadthe execution of trials for the research team
• You will plan and trackall assigned clinical activity in the lifecycle phases of thestartup,interim and close out
• You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians
• You will verify study procedures are performed within the protocol specified window
• You willparticipatein teleconferences with sponsors toupdate onpatients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff
• You will presentin weekly protocol meeting to investigators, research staff, and management
• You will providepertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria
• You will update internal research teams on protocol modifications and specifications including visit schedule,assessment windows, dose modifications, central and local laboratory assessments
• You will createstudy specific tools for source documentation including eligibility worksheets, screeningchecklists and worksheets capturing vital signs, blood sampling (as applicable)
• You will ensurestudy specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes
• You will investigateroot cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions
• You will ensurepharmacy has Investigative Productand supplies
• You will interfacewithlaboratory technician for lab kits and processing
• You will track and reportadverse events, serious adverse events, protocol waivers,deviationsandviolations
• You willparticipatein monitor visits for each assigned trial at each monitoring visit
• You will review and commenton monitor letters within 5 business days of receipt and insures resolution of open items
• You will reviewsource documentation and queries for missing documentation
• You will collect,completeand enterdata into study-specific case report forms or electronic datacapture systems within the contractually agreed upontimeframe
• You will maintaincase report forms tracking management database
• You will reviewtrial data for clinical relevance and answersappropriate queriesApprises researchscientists and management team of all study specific medical issues for guidance
• You will assistin ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events
• You will assistin external sponsor audit and US FDA inspection preparation, conduct, and close outprocessioning
• You will reviewand responds to audit findings and escalates issues
• You will maintainandarchivestudy documentation and correspondence per company policy
• You willreportspatientvisitand data entry information infinancialtracking system.
• You will provide required metrics to leadership
• You willinitiateimprovements to enhance the efficiency and the quality of the work performed on assigned projects
• You will adhere to professional standards and SOP’sestablishedfor clinical research
• You willassistinternal quality team in preparation for sponsor and US FDA audit teams

You should have for this role:

• An understanding ofclinical trial data.
• Knowledge of FDA guidelines and GCP isrequired.
• The ability to work independently in afast pacedenvironment.
• Interpersonal skills, detailed-orientedand meticulous.
• Computer skills with ability using clinical trial databases, electronic data capture, MSAccessor Excel
• Bachelor Degreeis preferred
• At least one year of experience in healthcare,researchor other science related field
• At least one year of experience planning and managing clinical trial process

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here .

As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.