Red Nucleus is hiring an Associate/Senior Associate, Clinical Operations to join our global team!
Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services, and medical communications solutions for the life sciences industry. Our global team is composed of nearly 800 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.
At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves. Our culture is about meaningful work, a true sense of community, and fun. We love to celebrate our people and we are proud to have been Internationally recognized as a “Great Place to Work".
How You Will Contribute
In this position, you will be working with our Clinical Research team. For more information, please visit ITC I Red Nucleus.
The RN Associate/Senior Associate, Clinical Operations is responsible for working with the Data Management, Product Management and Technical Delivery teams to operationalize clinical research studies, specifically those that include remote data capture such as videos, ePRO and eCOA. The role is responsible for detailed specification development, documentation, and supporting clinical operations, project management and delivery activities for Clinical and iTakeControl (ITC) client projects from conception to closeout.
Responsibilities:
- Be the point of contact, maintain daily interactions and lead calls with internal and external stakeholders with supervision.
- Manage project team timelines, milestones and adhere to deadlines with supervision.
- Provide clinical operations support including project, sponsor, site and vendor management with supervision.
- Supports clinical operations during study start-up and manages study and sponsor relationship.
- Understand real world protocols, data collection processes, and GxP processes.
- Participate in protocol design discussions.
- Understand study requirements, EDC and or EHR systems, user needs, and logical business requirements with guidance.
- Understand ePRO systems for patient-centric research, data collection, and patient engagement with guidance.
- Develop and manage required documentation including IRB submissions packages, training content, caregiver/site manuals with supervision.
- Collaborate with Data Manager to develop documentation including Data Management Plan and EDC supporting documentation such as CRF Specifications, eCRFs.
- Manages and leads Site Initiation Visits (SIV) and site/central rater training as needed with guidance.
- Support UAT and product launch requirements.
- Adhere to quality and compliance (g., SOPs, etc.) and regulatory requirements.
- Prioritize and manage project schedules and effectively report and communicate progress.
- Work closely with customers and other-cross functional team members, from biotech clients to technical developers.
- Perform literature searches to assist in addressing requests by the team or clients.
- Well organized, obsessed with details, and capable of juggling multiple projects.
- Be confident and comfortable asking questions in a time of need.
- Willing and eager to learn new technology and work with iOS and Android applications.
- Assist with quality control testing to requirements.
- Support team members.
Education, Experience, Training, and Knowledge
Education
- Undergraduate degree from an accredited University, or relevant professional experience.
Experience
- Experience with operationalizing clinical study protocols, amendments, observational research and/or registries.
- Professional experience within biopharma or pharmaceutical industry, contract research organization (CRO), clinical study site, or consulting.
- Knowledge of GCP, ICH, HIPAA, GDPR, and FDA requirements for human subject research and their application to clinical operations.
- Knowledge of registries and/or clinical drug development pathways, including Phase 1-3 studies.
- Experience in project management. This role is responsible for simultaneously managing several projects/studies with varied scope to different teams, vendors and clients.
Skills & Abilities
- Proficient in Microsoft Office (Word, PowerPoint, Excel), with awareness of project management software, technology management software, and research systems, such EDC, ePRO, or EHR systems.
- Excellent verbal and written communication skills. This role is responsible for facilitating project reviews with management as well as escalating and negotiating solutions when issues arise.
- Proactive in problem solving, creative in suggestions and flexible to implement.
- Collaborative in a team environment but also confident learning and working independently.
- Highly ethical.
- Comfortable learning new technologies, applications, and systems.
- Creative and passionate about innovation and work to high standards.
- Able to provide a relevant portfolio/history of projects, studies, or applications.
Preferred Qualifications/ Experience
- 0-10 years professional experience.
- Digital or mobile app experience.
- Rare diseases, gene therapy, long term follow up.
This job description has been designed to capture the essential functions of this job. It was not designed to contain or be interpreted as a comprehensive inventory of all the duties, responsibilities and qualifications required to perform this job. It is based on management’s assessment of the requirements and functions of the job as of the date this description was prepared. Management reserves the right to modify the description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet production, scheduling, or staffing needs.
What You Will Enjoy at Red Nucleus
- Competitive pay, incentives, retirement, and income security programs
- Comprehensive benefits and wellness programs focused on healthy lifestyles
- Generous paid time off, employee assistance programs and flexible work arrangements
- Performance driven environment including professional development and transfer opportunities
- People first culture fostering self expression, diversity, and a growth mindset
- Celebrations! We love to celebrate service anniversaries, holidays, diversity and inclusion events, project milestones and anything else that is meaningful to our employees
- Support of the community organizations you are passionate about
- Ongoing programs and events designed to bring our global team together
Diversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit. We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.
To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.
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