Remote, us / centralized research – clinical research coordinator (crc) / remote
Central clinical services is a clinical capability within the clinical design, delivery, and analytics organizationThe central clinical services study coordinator will provide leadership within clinical services supporting performance, delivery, and exceptional customer experiencesThe consultant will provide technical support within the team and with vendor partners and will navigate complexities within study operationsResponsibilities include direct communication and management of activities, assessments, and documentation for potential patientsThis role will also manage monitoring visits, data management, and query management, and ongoing inspection readiness.
Duties include but are not limited to:
Deliver education and facilitate patient consenting.
Initiate and foster all assessment scheduling, logistics, technology, and communication for patients, central raters, investigators, and other study-related entities including mri centers and infusion centers where applicable.
Maintain all study documentation and data entry into applicable technology solutions.
Contribute to process optimization
Lead decisions across studies and across vendors that impact central clinical services operations.
Make decisions in the best interest of the patient, investigator, and/or other site staff to drive improved experiences and optimal efficiency.
Serves as central clinical services expert and influences complex business and technical decision and process improvements.
Be responsible for vendor partner day-to-day operations and provide mentorship and training.
Provide expertise related to budget processes and identify strategic levers to acquire cost savings and efficiency gains.
Actively coordinate trial, country, and site-level tasks ensuring all study assessments are completed with the highest quality and within protocol parameters.
Coordinate financial responsibilities including purchase order creation, invoice management, study-specific center payments, and payment reconciliation.
Build and maintain relationships with study patients and the research team (pi, central raters, etc.) to enable an outstanding study experience.
Develop and implement methods, mechanisms, and tools to meet and measure investigator, patient, and vendor satisfaction.
Monitor site contacts (e.g., calls, written communication, etc.) and important metrics, to ensure ccs is in accordance with lilly standards (patient safety, medical quality, privacy, etc.) and external and regulatory requirements.
Generate, revise and train ccs team on-site documents (e.g., operational manual, faq document, etc.)
Organizational leadership and process improvement:
Develop strong partnerships with patients, investigators, and other site staff; manage internal relationships across the cdda (trial capabilities, site engagement, design hub, clinical development, asset team, cssp, cls, sd&a.)
Lead and be a resource for others on local regulations, laws, and guidance (e.g., fda, ich), quality and business systems, and good clinical practices (gcp) to achieve inspection readiness and detect and resolve quality issues.
Apply problem-solving skills and effectively partner with institutions, investigators, and the cross-functional study teams to resolve issues ensuring solutions meet regulatory and ich/gcp requirements.
Manages ethics review board interactions; interacts with auditors; supports inspections; builds and maintains strong investigator relationships.
Build, communicate, and execute site and country-level risk mitigation and contingency plans.
Basic requirements:
Bachelor`s degree in a scientific field or health-related field
+ 5 years` experience in clinical trials/development
Additional skills/preferences:
3+ years experience in working with and managing cros or external vendors for the execution of clinical trials
Solid understanding of good clinical practice
Demonstrated leadership skills with the ability to influence, achieve results through others, and lead across regions/geographies+ experience in supervision, coaching, and mentoring others
Demonstrated financial oversight, business development, business planning
Strong communication (both verbal and written) and language skills - ability to communicate effectively up and down in the organization
Strong organizational/planning skills
Fluent in english (fluency in spanish is a bonus)
Ability to develop and apply creative solutions
Experience in working cross-culturally and with virtual teams
Benefits offered:
Pto/vacation days, sick days, holidays.
100% paid medical, dental, and vision insurance50% for dependents.
Hsa plan
Short-term disability, long-term disability, life insurance.
Continued education allowance
Culture of growth and equality
401k plan and matching contribution
About us at care access, every day we are advancing medical breakthroughsWe’re uniting standard patient care with cutting-edge treatments and researchThe work that we do brings life-changing therapies to those who are in need and paves the way for newer and greater treatments to reach the worldWe’re proud to advance these breakthroughs and to work with the big players while also engaging with the very best physicians and caring for patientsThrough innovation and a unique technology-enabled service model, our team of experts is paving the way to take this vision forward.
We careOur values are rooted in being genuine, finding new ideas, and building something meaningfulInfluenced by our values, we have built a culture valuing communication and dialogue: we care about what everyone has to say and we spend energy on being equal and inclusiveAlong the way, we are caring for each other, accelerating medicine, and seeding a long-term impact for generations to come.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
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