CRISPR Therapeutics
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Manager, Infusion Nurse Expert
role at
CRISPR Therapeutics
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 teams 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 and 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.
Benefits CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in‑person interactions. Employees work at least three days on‑site, creating a collaborative work environment, mentorship opportunities, increased cross‑functional communication and chances 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.
Equal Employment Opportunity Statement 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.
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Manager, Infusion Nurse Expert
role at
CRISPR Therapeutics
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 teams 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 and 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.
Benefits CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in‑person interactions. Employees work at least three days on‑site, creating a collaborative work environment, mentorship opportunities, increased cross‑functional communication and chances 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.
Equal Employment Opportunity Statement 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.
#J-18808-Ljbffr