Central Study Coordinator Jobs

Care Access is delivering the future of medicine today! Care Access has a revolutionary model that

breaks down traditional barriers to clinical trials that limit participation among physicians and patients

to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of

critical and life-saving therapies.

We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for

the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine,

and seed a long-term impact for generations.

Central Clinical Services is clinical capability within the Clinical Design, Delivery and Analytics organization. The Coordinator will deliver an exceptional customer experience through delivery and execution of studies acting as a central study coordinator as an extension of the research site. The Coordinator is accountable for study delivery at the patient level and is expected to coordinate daily work using patient centric practices and a quality-first approach. Responsibilities include direct communication and management of activities, assessments and documentation for potential patients. This role will also manage monitoring visits, data management and query management and ongoing inspection readiness.

Deliver education and manage study patient screening through the Informed Consent. Clearly understand the the requirements for informed consent from research participants, and the principles and content of the key documents that ensure the protection of human participants in clinical research.

Initiate and foster all assessment scheduling, logistics, technology and communication for patient, 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.

Make decisions that optimize the experience within the study for the patient, investigator and/or other site staff.

Make decisions on daily prioritization of work.

Identify, communicate, and resolve site and study issues.

Serves as topic area expert.

Work within a team to offer suggestions for solutions to more complex, within study problems/issues and to enable process improvements.

Manage daily payments for study assessments by patients as needed.

Coordinate site and patient activities during all time points within each study.

Creates and maintains strong investigator relationships.

Build and maintain relationship with study patient and research team (PI, central raters, etc.) to enable exceptional study experience Quality checks performed for overall data integrity and process assurance

Ensure all visit data is complete and entered into EDC systems within required time frame. Support/answer queries within the expected time frame.

Complete ongoing trainings and adhere to system access guidelines

Correctly identifying, documenting and reporting AEs’ & SAE’s

Apply principles of biomedical science to investigational product discovery and development and health related behavioral interventions

Ability to analyze protocols to identify study endpoints and outcomes. Translate the protocol priorities into a study implementation plan to ensure study objectives are achieved in a timely and compliant manner

Develop strategies to minimize query generation. Guide and support on data collection and best practices to support core data related competencies.

Ensure site compliance with subject safety reporting, escalate issues and provide potential solutions to support CSC efforts.

Demonstrate advanced skills in navigating and troubleshooting a wide variety of e clinical technologies. Develop training materials and facilitate study team member training to accelerate the technology adoption learning curve with new technologies. Identify and explore opportunities to incorporate new technologies into site workflow practices to streamline study conduct activities.

Demonstrate professionalism and apply basic leadership practices in all aspects of the role of the CSC.

Demonstrate an understanding of when escalations need to be addressed. Address questions in a thoughtful manner and coordinates solutions with study team.

Organizational Leadership and Process Improvement

Manage tasks daily to ensure study assessments are completed on time and with the highest possible quality.

Ensure all requested and required guides are followed, documentation is maintained, and trackers/systems are up to date daily.

Establishes relationships to enable study level work both externally and internally.

Manage satisfaction of patients through outstanding interactions.

This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.

Understanding of the overall clinical development paradigm and the importance of efficient site activation

Applied knowledge of project management processes and skills

Appreciation of / experience in regulated environment

Strong communication (both verbal and written) and language skills ability to communicate effectively up and down in the organization

Knowledge of and ability to follow financial and legal guidelines and policies (budget and contract)

Problem-solving skills

Self-management and organizational skills

Must have 3-5yrs Clinical Research Coordinator experience, CCRC preferred

PTO/vacation days

Sick days, holidays

100% paid medical

Dental, and vision Insurance

75% for dependents.-HSA plan-Short-term disability

Long-term disability, and life Insurance

Culture of growth and equality

401k retirement plan

Diversity & Inclusion: We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. We do not discriminate based on race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status. At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled service model. 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. Care Access is unable to sponsor work visas at this time.