The Special Operations Coordinator is responsible for operational functions of projects carried out by this Division, in support of Science 37 research programs. He/she will be involved in the execution and delivery of Special Operations projects from beginning to end, with a special emphasis on patient engagement in the clinic. Special Operations projects typically include: Validation of instruments; Prototyping of processes, workflows, and technologies; and Sponsored Studies, all of which may include the consenting, screening, and enrollment of participants. Duties of the Spec Ops Coordinator may include various elements of: study setup and preparation; protocol and informed consent development; IRB submissions; essential document management; study data management; and overall study execution. Human subject studies require recruiting, enrolling and conducting follow-up of study participants in clinical trials under the direct supervision of the Principal Investigator. The Spec Ops Coordinator is responsible for coordinating trial participation of study volunteers according to the study 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 Spec Ops Coordinator is responsible for working with the Special Operations team to ensure the successful completion and execution of all projects within the department.

Duties and Responsibilities

• Assists in the implementation and execution of Special Operations projects (including Validation studies, Prototyping studies, and Internal R&D studies) in collaboration with team members.
• Assists in recruiting participants for Special Ops studies and Clinical Operations trials from local brick and mortar partner clinics.
• Assists in activities to initiate all Special Operations projects, in collaboration with team members, including protocol and synopsis design, IRB submissions, study document preparation and management, NORA platform development, and all other study-related activities.
• Collaborates with Data and Analytics team to identify public health topics related to trial patient populations and track metrics to inform global engagement.
• Communicates and connects with team members on a daily basis to stay informed and abreast of the goals and objectives of the department.
• Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives, including significant time spent in-clinic facilitating patient participation in studies.
• Interacts with potential study participants, by prescreening them for study protocol eligibility, presenting them with trial concepts and details, participating in the informed consent process along with the study investigator, and enrolling eligible participants in study protocols.
• Coordinates patient care in compliance with study protocol requirements, under the supervision of a study investigator.
• 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.
• Reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings, in collaboration with the study investigator.
• 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, severe adverse events, and source documents to ensure that research is being conducted according to guidelines.
• Responsible for accurate and timely data collection, documentation, entry, and reporting.
• Participates in required training and education programs.
• 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.

Qualifications

• Bachelor’s degree required
• A minimum of at least 1+ years of clinical research experience (or similar relevant experience) is strongly preferred.
• Medical and scientific knowledge preferred.
• Knowledge of Good Clinical Practice and applicable regulatory requirements preferred.
• Fluency in Spanish preferred.

Skills/Competencies

• Strategic thinking and problem-solving – Demonstrates independence and self-motivation to solve problems and work productively in a team environment.
• Knowledge of clinical research – Demonstrates an ability to successfully manage the participation of patients in clinical trials, and understands the critical elements for success in research.
• Knowledge of GCP guidelines – Understands applicable regulations and implications for trial participation.
• Strong communication and presentation skills – Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive personal relationships within Science37, and externally. Ability to interact with patients and caregivers in a compassionate and empathetic manner.
• Computer skills – Working knowledge of MS Office suite and Google applications. Ability 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 adherence to concepts of teamwork, cooperation, self-control, and flexibility to get work done. Ability to adapt to a rapidly changing work environment. 

Capabilities

• Up to 20% travel, for project team meetings, client presentations and other professional meetings/conferences, as needed.
• Ability to communicate in English (both verbal and written).

Science 37 values the well-being of its employees and aims 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. Submit your resume to apply!