Senior Clinical Research Associate
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Senior CRA will enable AbbVie’ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies.
Responsibilities:
For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out.
Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports.
Anticipate and identify site issues that could affect timelines and develop alternative solutions.
Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise.
Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
Ensure audit and inspection readiness of assigned sites.
Advise on pre-audit activities for GCP requirements.
Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
May be responsible for being the country point of contact for CROs for an assigned study.
May participate/lead in global/local task forces and initiatives.
Responsible for activities as assigned by manager.
If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally.
Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
If assigned; With guidance, may serve as key point of contact in country/district for assigned study. Update Impact/Tesla with country level information: Country-level planning timelines, LSR assignments, etc.
If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site monitors
Qualifications
Minimum Qualifications:
Bachelors degree
3+ years of Site Monitoring Experience
Preferred Qualifications:
Health Related degree: e.g. Medical, Scientific, Nursing, Pharmacy
Other Required Skills:
Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
Demonstrated proactive and positive team player.
Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
Demonstrated business ethics and integrity.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
About the job
Apply for this position
Senior Clinical Research Associate
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Senior CRA will enable AbbVie’ s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies.
Responsibilities:
For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out.
Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports.
Anticipate and identify site issues that could affect timelines and develop alternative solutions.
Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise.
Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
Ensure audit and inspection readiness of assigned sites.
Advise on pre-audit activities for GCP requirements.
Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
May be responsible for being the country point of contact for CROs for an assigned study.
May participate/lead in global/local task forces and initiatives.
Responsible for activities as assigned by manager.
If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally.
Provide consistent best practice approach to onboarding, consolidating “lessons learned” across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
If assigned; With guidance, may serve as key point of contact in country/district for assigned study. Update Impact/Tesla with country level information: Country-level planning timelines, LSR assignments, etc.
If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site monitors
Qualifications
Minimum Qualifications:
Bachelors degree
3+ years of Site Monitoring Experience
Preferred Qualifications:
Health Related degree: e.g. Medical, Scientific, Nursing, Pharmacy
Other Required Skills:
Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
Demonstrated proactive and positive team player.
Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
Demonstrated business ethics and integrity.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html