Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients’ homes. By leveraging the latest innovations in mobile technology, cloud services, telemedicine, and mass-engagement channels like Facebook and Google, we are breaking down traditional geographic barriers to patient trial participation while shortening the time needed to bring new treatments to market.
We value employee well-being and aim to provide team members with everything they need to succeed. Enjoy daily healthy catered lunches, snacks and beverages, and top-notch equipment such as the latest Macbook Pro, 4k monitors, and adjustable standing desks.
The Senior Clinical Research Coordinator fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials related to Diabetes, Neurology and Psychiatry. In doing so, the Senior Clinical Research Coordinator is responsible for coordinating trial participation of study volunteers with the trial’s protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol.
Duties & Responsibilities
Under direct supervision of a principal investigator, is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials.
Collaborates with study investigator in determining eligibility of potential participants in clinical trials.
Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol.
Ensures research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide participants education regarding medication administration. Maintains investigational drug accountability.
In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
Maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements.
Ensures the completion and maintenance of consent forms, case report forms, SAE’s and source documents to ensure that research is being conducted according to guidelines.
Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives.
Maintains regulatory documents in accordance with SOPs and applicable regulations.
Prepare, submit, and maintain IRB approval materials.
Participates in required training and education programs. Responsible for education of other personnel and vendors regarding clinical research.
Will collaborate with Project Manager to ensure compliance to trial procedures and vendor management.
Additional responsibilities may include working directly with other vendors and/or sponsors.
Provide a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Bachelor’s degree preferred; Advanced degree suggested or equivalent clinical research experience
7+ years of pharmaceutical-sponsored clinical research experience or equivalent applicable experience
Medical and scientific knowledge preferred.
Experience in the following therapeutic areas preferred/a plus: Diabetes, Neurology and Psychiatry.
Expertise in trial management – demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem solving abilities and follow through.
Expert Knowledge of FDA regulations and GCP guidelines – Understands applicable regulations and implications for trial participation.
Expert knowledge of clinical research – Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities.
Strong communication and presentation skills – Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive study participant, project team member and internal Science37 relationships. Ability to interact with patients and caregivers in a compassionate and empathetic manner.
Computer skills – Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. Willingness to gain expertise in the use of propriety software.
Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making.
Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed
Ability to communicate in English (both verbal and written)
Science 37 uses advanced telemedicine technology and patient-centric innovative networked clinical research models to rapidly accelerate biomedical discovery and bring down the costs of clinical trials. In addition to our own researchers, we also work closely with top physician-scientists and leading telemedicine companies. S37 offers full support and end-to-end services for Networked Clinical T...rials. If you are an investigator, an inventor, a small biotech company or a large pharmaceutical company, we can help you achieve your clinical trial goals faster and easier than ever before.
Based in Los Angeles, we are focused on the development of networked patient-centric models for clinical research to rapidly accelerate biomedical discovery. We leverage partnerships with national mobile nursing companies, pharmacy chains, patient advocacy groups, virtual e-consenting, mobile devices, and other technology companies to maximize efficiency. Then, using design-thinking principles and rapid prototyping…S37 puts patients first and brings the best clinical trials right to their homes. One incredible benefit of the S37 approach is that by making trials better for patients, we ultimately make the process of biomedical discovery faster and less expensive. This means more safe and effective treatments will reach patients faster and cost less.
Our proprietary technology platform, NORA (Network-Oriented Research Assistant), bridges the gap between traditional trial management software, an EMR, and an advanced telemedicine platform to support all participants in Networked Clinical Trials (NCTs). We utilize telemedicine, networked investigators, unique industry partnerships, proprietary software technologies, innovative patient engagement methods, industry-integrated software, and centralized regulatory processes to make clinical research faster, safer, and less expensive.