Sr. Clinical Research Liaison
About Pacira
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together.
At Pacira Biosciences, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical outcomes.
Summary:
The Senior Clinical Research Liaison will function as the Lead in the development, monitoring, and completion of clinical registries. This position will be the primary contact with healthcare professionals (HCPs), key opinion leaders (KOLs), as well as the steering committee members and study site staff involved with clinical registries. The individual will provide guidance to study sites to help ensure data capture of high-quality clinical data and estimating project requirements and project coordination. The individual will also collaborate with members of the Medical Science and Clinical Operations team to provide relevant clinical context to studies.
Essential Duties &
Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
Understand products, existing literature, registry/study protocols, and therapeutic area in sufficient detail to discuss with HCPs, KOLs, steering committee members and the study site personnel on the technical and clinical aspects of the registries.
Lead/Attend Site Initiation Visits, Interim Monitoring Visits, and other visits as needed for collaboratives and sponsored studies.
Conduct site visit, site training and on-site observation. Document the on-site findings, communicate with the study personnel any technical issues identified during the site visit and follow up after the visit to ensure the closure of the issues.
Actively assists with providing oversight to assure investigator compliance with the study protocols, regulatory guidelines, and company standard operating procedures.
Actively participate in study management with the cross functional team (medical directors, clinical operations, safety, data management/statistics and regulatory, etc.).
Participate in steering committee and site personnel meetings, to ensure the team will achieve key study milestones including timeline and ensure high data quality from the studies assigned.
Participate in study related document development and review, including study protocols, IRB submissions, and SOPs.
Develop and maintain relationships with study sites through effective and timely communication.
Provide support to site investigators and study coordinators to resolve site related issues.
Maintain a working knowledge of HIPAA, GCP and 21 CFR 812.
Assist with additional tasks as assigned, including providing clinical context and support for health outcomes studies.
Maintain credentialling to obtain access to various study sites and operating theatres.
Monitor and support use of electronic data capture system, with understanding of case report forms and database builds.
Monitor and support use of Pacira products and clinical applications within research protocols as appropriate.
Manage budgets and timelines for all registries and hold responsibility for reporting their status.
Develop and maintain information on registry website.
Prepare weekly reports on study updates, publications and compile surgical area specific dashboards for reporting to senior management.
Education and
Experience:
Bachelor's or master's degree in the science/health care field, a nursing degree, or equivalent combined education. Orthopedic experience preferred.
7-10 years of clinical/scientific research experience or relevant work in the biosciences industry.
Supervisory
Responsibilities:
This position does not have supervisory responsibilities.
Interaction:
The position works closely with the HCPs, KOLs, investigators, site study stuff, clinical operations staff, Medical Science staff and pharmacovigilance/safety staff, to assure the timely and effective support of registries and health outcomes studies.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities:
Demonstrated dependability, flexibility, and maturity.
Positive, even-tempered, and effective in building interpersonal working relationships with various clinical personnel.
Excellent written and oral English communication and presentation skills.
Proven ability to work effectively on a team in an entrepreneurial environment.
Strong organization and documentation skills.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
Demonstrated working knowledge of GCP, ICH, and other relevant clinical development regulations and processes are preferred.
Travel Requirement:
Up to 30% travel required
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Will need to lift and move boxes of paper and binders weighing up to 20 pounds. This position requires considerable hospital presence and requires the ability to walk and stand for periods of time.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
This position requires considerable on-site presence at clinical trial sites. Ability to function independently using remote office tools.
Benefits:
Medical, Prescription, Dental, Vision Coverage
Flexible Spending Account & Health Savings Account with Company match
Employee Assistance Program
Mental Health Resources
Disability Coverage
Life insurance
Critical Illness and Accident Insurance
Legal and Identity Theft Protection
Pet Insurance
Fertility and Maternity Assistance
401(k) with company match
Flexible Time Off (FTO) and 11 paid holidays
Paid Parental LeaveEstimated Salary: $20 to $28 per hour based on qualifications.
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let's pursue excellence together.
At Pacira Biosciences, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical outcomes.
Summary:
The Senior Clinical Research Liaison will function as the Lead in the development, monitoring, and completion of clinical registries. This position will be the primary contact with healthcare professionals (HCPs), key opinion leaders (KOLs), as well as the steering committee members and study site staff involved with clinical registries. The individual will provide guidance to study sites to help ensure data capture of high-quality clinical data and estimating project requirements and project coordination. The individual will also collaborate with members of the Medical Science and Clinical Operations team to provide relevant clinical context to studies.
Essential Duties &
Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
Understand products, existing literature, registry/study protocols, and therapeutic area in sufficient detail to discuss with HCPs, KOLs, steering committee members and the study site personnel on the technical and clinical aspects of the registries.
Lead/Attend Site Initiation Visits, Interim Monitoring Visits, and other visits as needed for collaboratives and sponsored studies.
Conduct site visit, site training and on-site observation. Document the on-site findings, communicate with the study personnel any technical issues identified during the site visit and follow up after the visit to ensure the closure of the issues.
Actively assists with providing oversight to assure investigator compliance with the study protocols, regulatory guidelines, and company standard operating procedures.
Actively participate in study management with the cross functional team (medical directors, clinical operations, safety, data management/statistics and regulatory, etc.).
Participate in steering committee and site personnel meetings, to ensure the team will achieve key study milestones including timeline and ensure high data quality from the studies assigned.
Participate in study related document development and review, including study protocols, IRB submissions, and SOPs.
Develop and maintain relationships with study sites through effective and timely communication.
Provide support to site investigators and study coordinators to resolve site related issues.
Maintain a working knowledge of HIPAA, GCP and 21 CFR 812.
Assist with additional tasks as assigned, including providing clinical context and support for health outcomes studies.
Maintain credentialling to obtain access to various study sites and operating theatres.
Monitor and support use of electronic data capture system, with understanding of case report forms and database builds.
Monitor and support use of Pacira products and clinical applications within research protocols as appropriate.
Manage budgets and timelines for all registries and hold responsibility for reporting their status.
Develop and maintain information on registry website.
Prepare weekly reports on study updates, publications and compile surgical area specific dashboards for reporting to senior management.
Education and
Experience:
Bachelor's or master's degree in the science/health care field, a nursing degree, or equivalent combined education. Orthopedic experience preferred.
7-10 years of clinical/scientific research experience or relevant work in the biosciences industry.
Supervisory
Responsibilities:
This position does not have supervisory responsibilities.
Interaction:
The position works closely with the HCPs, KOLs, investigators, site study stuff, clinical operations staff, Medical Science staff and pharmacovigilance/safety staff, to assure the timely and effective support of registries and health outcomes studies.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities:
Demonstrated dependability, flexibility, and maturity.
Positive, even-tempered, and effective in building interpersonal working relationships with various clinical personnel.
Excellent written and oral English communication and presentation skills.
Proven ability to work effectively on a team in an entrepreneurial environment.
Strong organization and documentation skills.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
Demonstrated working knowledge of GCP, ICH, and other relevant clinical development regulations and processes are preferred.
Travel Requirement:
Up to 30% travel required
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Will need to lift and move boxes of paper and binders weighing up to 20 pounds. This position requires considerable hospital presence and requires the ability to walk and stand for periods of time.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
This position requires considerable on-site presence at clinical trial sites. Ability to function independently using remote office tools.
Benefits:
Medical, Prescription, Dental, Vision Coverage
Flexible Spending Account & Health Savings Account with Company match
Employee Assistance Program
Mental Health Resources
Disability Coverage
Life insurance
Critical Illness and Accident Insurance
Legal and Identity Theft Protection
Pet Insurance
Fertility and Maternity Assistance
401(k) with company match
Flexible Time Off (FTO) and 11 paid holidays
Paid Parental LeaveEstimated Salary: $20 to $28 per hour based on qualifications.
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