Manager, Infusion Nurse Expert

CRISPR Therapeutics•South Boston, MA

2d•$118,000 - $130,000•Hybrid

About The Position

Responsibilities Participate in the design and implementation of successful infusion protocols, cross functional SOPs, and scientific training material to support clinical trials. Develop infusion and protocol training materials to support internal and external activities Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, regulatory affairs, etc.) to ensure successful translation of the clinical protocol into operational deliverables, and participate in the design and development of shared process improvement programs Collaborate with analytical laboratory personnel to assist with drug product thaw and infusion process testing Train clinical sites on receipt, storage, thaw, and infusion procedures related to CRISPR Therapeutics drug products and collaborate with clinical infusion sites to ensure subject safety, adherence to GCP, GxP, GDP and compliance with study protocol Assess and document the effectiveness of education provided to clinical sites, including the activation of new sites to the clinical trial Participate in study site selection by evaluating a site’s ability to comply with CRISPR Therapeutics requirements for receipt, storage, thaw, and infusion procedures Provide continuous on-site or remote support for all drug product programs which includes working outside of normal business hours, (i.e. nights, weekends and holidays) Work with cross-functional team to identify opportunities to improve processes and products, including apheresis, as needed by GMP manufacturing; this may include updates to vendor procedures or processes and supporting change documentation by CRISPR Minimum Qualifications Advanced degree in a scientific discipline such as: RN and 5-7+ years' clinical experience, preferably in hospital inpatient or pharmacy setting Pharm D or PhD 1-3+ years' clinical experience, preferably in hospital inpatient or pharmacy setting Excellent oral and written communication skills Experience working with MS PowerPoint, MS Word, MS Excel, Teams and SharePoint as well as Zoom video conferencing Ability to work collaboratively in a fast-paced, team-based matrix environment A thorough understanding of ICH, GCP, GDP and relevant regulatory requirements Strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators. Preferred Qualifications Experience with infusion procedures Experience with clinical education Competencies Collaborative – Openness, One Team Undaunted – Fearless, Can-do attitude Results Orientation – Delivering progress toward our mission, Sense of urgency in solving problems Entrepreneurial Spirit – Proactive, Ownership mindset CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. Base pay range of $118,000 to $130,000+ bonus, equity and benefits The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities. CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

Requirements

Advanced degree in a scientific discipline such as: RN and 5-7+ years' clinical experience, preferably in hospital inpatient or pharmacy setting
Pharm D or PhD 1-3+ years' clinical experience, preferably in hospital inpatient or pharmacy setting
Excellent oral and written communication skills
Experience working with MS PowerPoint, MS Word, MS Excel, Teams and SharePoint as well as Zoom video conferencing
Ability to work collaboratively in a fast-paced, team-based matrix environment
A thorough understanding of ICH, GCP, GDP and relevant regulatory requirements
Strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators.

Nice To Haves

Experience with infusion procedures
Experience with clinical education

Responsibilities

Participate in the design and implementation of successful infusion protocols, cross functional SOPs, and scientific training material to support clinical trials.
Develop infusion and protocol training materials to support internal and external activities
Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, regulatory affairs, etc.) to ensure successful translation of the clinical protocol into operational deliverables, and participate in the design and development of shared process improvement programs
Collaborate with analytical laboratory personnel to assist with drug product thaw and infusion process testing
Train clinical sites on receipt, storage, thaw, and infusion procedures related to CRISPR Therapeutics drug products and collaborate with clinical infusion sites to ensure subject safety, adherence to GCP, GxP, GDP and compliance with study protocol
Assess and document the effectiveness of education provided to clinical sites, including the activation of new sites to the clinical trial
Participate in study site selection by evaluating a site’s ability to comply with CRISPR Therapeutics requirements for receipt, storage, thaw, and infusion procedures
Provide continuous on-site or remote support for all drug product programs which includes working outside of normal business hours, (i.e. nights, weekends and holidays)
Work with cross-functional team to identify opportunities to improve processes and products, including apheresis, as needed by GMP manufacturing; this may include updates to vendor procedures or processes and supporting change documentation by CRISPR