Virtual Site Director

This is a fully Remote and Work From Home (WFH) opportunity within the US

Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. The Science 37 Operating System (OS) enables universal access to patients and providers, leading to faster enrollment, greater retention and a more representative patient population. To help us achieve our goal, we are seeking a Virtual Site Director eager to make an impact within a mission-driven organization.

The Virtual Site Director is responsible for the operational oversight and daily management of Clinical Research Coordinator team and Virtual Site Managers. The Virtual Site Director will problem-solve complex situations, develop and implement group training, and process and document best practices.

DUTIES & RESPONSIBILITIES

Duties include but are not limited to:

1. Manage Virtual Site Managers/Clinical Research Coordinators workload and work assignments
2. Supervise Virtual Site Managers/Clinical Research Coordinators; meet with Clinical Research Coordinator team regularly and communicate performance expectations and guidelines
3. Determine needed project processes. Train and maintain project team knowledge/application of project processes. Modify practices and procedures to improve efficiency and quality
4. Assist Corporate Trainer with the development, oversight and delivery of project team training and training materials, as needed
5. Facilitate communication with investigators to assure understanding of expectations and work scope
6. Work with the Clinical Project Managers and Corporate Trainer to ensure Clinical Research Coordinators are adequately trained for their respective study responsibilities and participate in review of protocols
7. Oversee the Clinical Research Coordinator new hire process to ensure that Clinical Research Coordinators have completed the appropriate training
8. Promote effective teamwork among Clinical Research Coordinators and provide ongoing direction and management to develop skills for Clinical Research Coordinators
9. Assist with development and upkeep of Clinical Research Coordinator duties and work instructions
10. Meet with Investigators/Clinical Project Managers/Director of Clinical Operations/SVP Clinical Operations/ Corporate Trainer to understand Clinical Research Coordinator needs
11. Participate in project meetings as needed
12. Identify and recommend improvement initiatives
13. Problem-solve varied solutions that require significant analysis or interpretation and investigative solutions
14. 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
15. Assist in training Clinical Research Coordinators to review study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings, depending on appropriate degrees and certification
16. Responsible for insuring Clinical Research Coordinators complete accurate and timely data collection, documentation, entry, and reporting.
17. Supervise and manage Clinical Research Coordinators as they prepare, submit, and maintain IRB approval materials
18. Participate in required training and education programs. Responsible for education of other personnel and vendors regarding clinical research, as necessary
19. Will collaborate with Clinical Project Manager to ensure compliance to trial procedures and vendor management
20. Train Clinical Research Coordinators to provide a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards
21. Oversees, mentors and builds Clinical Research Coordinator team; guides them through studies, processes, issues
22. Conducts performance reviews, calibration sessions and feedback discussions. Performs competency assessments across his/her team, and implements and monitors development plans with direct reports
23. Assists in the interviewing of potential Clinical Research Coordinator candidates
24. Works with and advises the Director(s) of Clinical Operations and Clinical Project Managers to identify the appropriate Clinical Research Coordinator for trial studies based on the individuals experience, knowledge, etc.

QUALIFICATIONS & SKILLS

Qualifications

1. Bachelor’s degree required; advanced degree, a plus
2. 7 years of pharmaceutical-sponsored clinical research experience
3. 3-5 years of experience managing Clinical Research Coordinators
4. Experience building, managing, and guiding individual(s) and/or a team strongly preferred
5. Medical and scientific knowledge strongly preferred

Skills/Competencies

1. Expertise in trial management - demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem solving abilities and follow through
2. Personnel management and team leadership skills- demonstrated ability to train, coach and evaluate clinical trial team members. Strong focus on collaboration and ability to direct work
3. Extensive Knowledge of FDA regulations and GCP guidelines – Understands applicable regulations and implications for trial participation
4. Extensive knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities
5. 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
6. 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
7. 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
8. Problem Solving – proactive problem-solving ability and follow-through
9. Interpersonal Savvy - Understands interpersonal and group dynamics and reacts in an effective and tactful manner and has a range of interpersonal skills and approaches with ability to select a best-fit approach
10. Ability to motivate & influence - Ability to motivate, influence and guide team members and direct reports; gains commitments from others.
11. Build & Manage Teams - Experience in building and guiding organizational teams. Leverages each team member’s unique background and perspective to achieve team goals while providing clear direction and accountabilities. Commitment to collaboration, within and across departments

Capabilities 

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

REPORTING

The incumbent reports to the Vice President, Clinical Operations, who will also assign projects, provide general direction and guidance. Incumbent is expected to perform duties and responsibilities with minimal supervision.

DIRECT REPORTS

1. Clinical Research Managers
2. Clinical Research Coordinators

Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.

Submit your resume to apply!