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 Clinical Research Manager eager to make an impact within a mission-driven organization.
The Clinical Research Manager is responsible for the operational oversight and daily management of Clinical Research Coordinators. As team manager, the individual has the discretion to make daily operational decisions, guided by an understanding of best practices, as well as convincingly recommending process improvements. The Clinical Research Manager will problem-solve complex situations which require integrative solutions and an understanding of the smallest details of clinical research. The Clinical Research Manager is responsible for overseeing the coordination of trial participation and 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 Manager is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol.
DUTIES AND RESPONSIBILITIES
Duties include but are not limited to:
- Manage Clinical Research Coordinators (CRCs) workload and work assignments.
- Supervise CRCs; meet with CRC team regularly and communicate performance expectations and guidelines.
- Determine needed project processes. Train and maintain project team knowledge/application of project processes. Modify practices and procedures to improve efficiency and quality.
- Assist Corporate Trainer with the development, oversight and delivery of project team training and training materials, as needed.
- Apply clinical research knowledge and broad understanding of functional areas to develop solutions to complex problems.
- Facilitate communication with investigators to assure understanding of expectations and work scope.
- Work with the Project Manager and Corporate Trainer to ensure CRCs are adequately trained for their respective study responsibilities and participate in review of protocols.
- Oversee the CRC new hire process to ensure that CRAs have completed the appropriate training.
- Promote effective teamwork among CRCs and provide ongoing direction and management to develop skills for CRCs.
- Assist with development and upkeep of CRC duties and work instructions.
- Meet with Investigators/Project Managers/Director of Clinical Operations/SVP Clinical Operations/ Corporate Trainer to understand CRC needs.
- Participate in project meetings.
- Identify and recommend improvement initiatives.
- Problem-solve varied solutions that require significant analysis or interpretation and investigative solutions.
- Ensure research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
- Manage the coordination of patient care in compliance with protocol requirements. May disburse investigational drug and provide participants education regarding medication administration, depending on appropriate degree and certification.
- Maintain investigational drug accountability, depending on appropriate degrees and certification.
- Assist in training CRCs 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.
- Responsible for insuring CRCs complete accurate and timely data collection, documentation, entry, and reporting.
- Schedule and participate in monitoring and auditing activities.
- Maintain 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.
- Ensure 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.
- Maintain regulatory documents in accordance with SOPs and applicable regulations.
- Supervise and manage CRCs as they prepare, submit, and maintain IRB approval materials.
- Participate in required training and education programs. Responsible for education of other personnel and vendors regarding clinical research, as necessary.
- Collaborate with Project Manager to ensure compliance to trial procedures and vendor management.
- Train CRCs 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.
- Oversee, mentor and build Clinical Research Coordinator team.
- Mentor CRCs and guide them through studies, processes, issues.
- Conduct performance reviews, calibration sessions and feedback discussions. Performs competency assessments across his/her team, and implements and monitors development plans with direct reports.
- Assists in the interviewing of potential CRC candidates.
- Work with and advises the Virtual Site Director, Director(s) of Clinical Operations and Project Managers to identify the appropriate CRC for trial studies based on the individuals experience, knowledge, etc.
QUALIFICATIONS & SKILLS
- Bachelor’s degree required; advanced degree, a plus.
- 7+ years of pharmaceutical-sponsored clinical research experience.
- 3-5+ years of experience managing Clinical Research Coordinators
- Experience building, managing, and guiding individual(s) and/or a team, strongly preferred.
- Medical and scientific knowledge, strongly preferred.
- Expertise in trial management. Demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem solving abilities and follow through.
- 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.
- Extensive Knowledge of FDA regulations and GCP guidelines. Understands applicable regulations and implications for trial participation.
- 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.
- 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.
- Problem Solving. Proactive problem-solving ability and follow-through.
- 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.
- Ability to motivate & influence. Ability to motivate, influence and guide team members and direct reports; gains commitments from others.
- Build and 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.
- 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)
The incumbent reports directly to the Virtual Site Director who will also assign projects, provide general direction and guidance and indirect reporting to the VP of Clinical Operations. Incumbent is expected to perform duties and responsibilities with minimal supervision.
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!