What are the responsibilities and job description for the In-House Clinical Research Associate position at BioSpace?
About The Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?
The Position
Takes ownership to deliver upon Clinical Development and Operations (CDO) goals, including successful delivery of trials. Responsible for site engagement by being the primary point of contact for site related issues. Drives study start-up, recruitment and retention on a site level to ensure site specific metrics are met. Contributes to improvement/innovation projects for CDO and/or as part of a global team and as aligned to a business case, goals and/or future aspirations. Contributes to a continually changing environment, supporting a future focused approach, leveraging competencies, tools and technology.
Relationships
Reports to the Manager (or above) within CDO. Builds and maintains strong relationships with external stakeholders relevant to the execution of clinical trials and support of clinical trial sites (e.g., clinical trial site staff, IRBs, clinical research vendors). Manage relationships with multiple internal stakeholders relevant to the execution of clinical trials and support of clinical trial sites (e.g., across CDO, CMR, International Operations (IO), HQ R&D and Commercial).
Essential Functions
Site Support: Serve as the primary point of contact for clinical trial sites, offering guidance, support, and training as needed to ensure trial targets are met as well as protocol and regulatory compliance; triaging support requests to appropriate trial team members as appropriate; work closely with CRAs in overall site management
Start-up: Performs site selection visits (SSV) as needed. Drives site activation through regulatory document collection, review, and tracking, including required study staff training completion and system access in alignment with trial start-up strategies
Systems: Ensures study systems (e.g. COSMOS) are updated per expectations/requirements; Provides system expertise to train and support clinical trial sites, including managing system access; ensuring coverage of designated site communication systems (eg, central email “mailboxes”)
Execution: Track patient recruitment and assist with recruitment efforts by maintaining regular site contact; assist with patient retention oversight as per local strategy; assist with oversight of site EDC data entry and data query resolution
Closure: Provides support to clinical trial sites during trial closure, including data cleaning/database lock and site closeout
Quality: Provides support for trial and site audits and health authority inspections; assist the CRA with site Action Item and Protocol Deviation review and follow-up
Development: Demonstrates technical proficiency within responsible areas, stays up to date on new processes, systems, and technologies while building knowledge of emerging trends and advances within area
Collaboration: Contributes actively to Trial Core Team and other relevant teams
Physical Requirements
0-10% overnight travel required; May be required to work company holidays and weekends.
Qualifications
A Bachelor’s degree (science-related discipline preferred) or a Registered Nurse (RN) degree is required
A minimum of 3 years of experience in the planning and conduct of GCP clinical trials, some of more recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical, biotechnology, CRO, and/or healthcare setting required
A minimum of 2 years of direct expertise of site management and logistical execution of clinical trials required
Relevant Novo Nordisk experience will apply where appropriate
Site activation and site management/monitoring experience is an asset
Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials
Demonstrated computer skills (MS Office, clinical trial systems) and adaptability to new systems
Excellent communications skills (verbal, written, presentation) in English
Demonstrated collaborative and stakeholder management skills
This Position Is Part Of a Job Family. Title And Level Within The Job Family Are Evaluated Based On a Number Of Factors, Such As Years Of Experience, Scope Of Work, Proficiency, And Business Need. Candidates Will Be Assessed For The Most Appropriate Title And Level Within The Job Family During The Recruitment Process. The Base Range Of Pay For Each Title In This Job Family Are As Follows
In-House Clinical Research Associate - $100,000 to $120,000
Senior In-House Clinical Research Associate - $115,000 to $150,000
In addition, this position is eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?
The Position
Takes ownership to deliver upon Clinical Development and Operations (CDO) goals, including successful delivery of trials. Responsible for site engagement by being the primary point of contact for site related issues. Drives study start-up, recruitment and retention on a site level to ensure site specific metrics are met. Contributes to improvement/innovation projects for CDO and/or as part of a global team and as aligned to a business case, goals and/or future aspirations. Contributes to a continually changing environment, supporting a future focused approach, leveraging competencies, tools and technology.
Relationships
Reports to the Manager (or above) within CDO. Builds and maintains strong relationships with external stakeholders relevant to the execution of clinical trials and support of clinical trial sites (e.g., clinical trial site staff, IRBs, clinical research vendors). Manage relationships with multiple internal stakeholders relevant to the execution of clinical trials and support of clinical trial sites (e.g., across CDO, CMR, International Operations (IO), HQ R&D and Commercial).
Essential Functions
Site Support: Serve as the primary point of contact for clinical trial sites, offering guidance, support, and training as needed to ensure trial targets are met as well as protocol and regulatory compliance; triaging support requests to appropriate trial team members as appropriate; work closely with CRAs in overall site management
Start-up: Performs site selection visits (SSV) as needed. Drives site activation through regulatory document collection, review, and tracking, including required study staff training completion and system access in alignment with trial start-up strategies
Systems: Ensures study systems (e.g. COSMOS) are updated per expectations/requirements; Provides system expertise to train and support clinical trial sites, including managing system access; ensuring coverage of designated site communication systems (eg, central email “mailboxes”)
Execution: Track patient recruitment and assist with recruitment efforts by maintaining regular site contact; assist with patient retention oversight as per local strategy; assist with oversight of site EDC data entry and data query resolution
Closure: Provides support to clinical trial sites during trial closure, including data cleaning/database lock and site closeout
Quality: Provides support for trial and site audits and health authority inspections; assist the CRA with site Action Item and Protocol Deviation review and follow-up
Development: Demonstrates technical proficiency within responsible areas, stays up to date on new processes, systems, and technologies while building knowledge of emerging trends and advances within area
Collaboration: Contributes actively to Trial Core Team and other relevant teams
Physical Requirements
0-10% overnight travel required; May be required to work company holidays and weekends.
Qualifications
A Bachelor’s degree (science-related discipline preferred) or a Registered Nurse (RN) degree is required
A minimum of 3 years of experience in the planning and conduct of GCP clinical trials, some of more recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical, biotechnology, CRO, and/or healthcare setting required
A minimum of 2 years of direct expertise of site management and logistical execution of clinical trials required
Relevant Novo Nordisk experience will apply where appropriate
Site activation and site management/monitoring experience is an asset
Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials
Demonstrated computer skills (MS Office, clinical trial systems) and adaptability to new systems
Excellent communications skills (verbal, written, presentation) in English
Demonstrated collaborative and stakeholder management skills
This Position Is Part Of a Job Family. Title And Level Within The Job Family Are Evaluated Based On a Number Of Factors, Such As Years Of Experience, Scope Of Work, Proficiency, And Business Need. Candidates Will Be Assessed For The Most Appropriate Title And Level Within The Job Family During The Recruitment Process. The Base Range Of Pay For Each Title In This Job Family Are As Follows
In-House Clinical Research Associate - $100,000 to $120,000
Senior In-House Clinical Research Associate - $115,000 to $150,000
In addition, this position is eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Salary : $100,000 - $120,000