Verified Job
Work from home
Senior CRA
Work from home
#5499
Remote / WFH
Novartis
Job Description
This is a remote position where candidates must be located near an airport (Texas, Louisiana, Arkansas, Oklahoma or New Mexico are highly desirable locations). The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Pharma clinical trials within the country. The Senior CRA is responsible for delivering data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs.
Internal job title: CRA II
Location: Remote (Texas, Louisiana, Arkansas, Oklahoma or New Mexico)
Job description
Key responsibilities: Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis)
Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
Facilitates the preparation and collection of site and country level documents
Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects and performs continuous training for amendments and new site personnel as required ensuring thorough documentation in Monitoring Visit Reports
Conducts continuous monitoring activities (onsite and/or remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety.
Accountable for continuously updating all relevant electronic systems to perform job functions
Takes on the responsibility as SME (Subject Matter Expert) as needed
Monitors studies as per current legislations, ICH/GCP and Novartis standards
Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring.
Identifies, resolves & escalates issues appropriately
Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry
Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as well as Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to achieve key accountabilities
Partners with SSU CRA to ensure seamless transition of site responsibility
Essential Requirements:
Minimum of 3 years’ experience in site monitoring
BS/BA degree. Scientific, Healthcare or other related field.
Excellent knowledge of the drug development process specifically clinical trial/research
Knowledge of international standards (GCP/ICH, FDA, EMEA)
Ability to manage multiple priorities and manage time efficiently.
Excellent Site management capabilities with demonstrated negotiating and problem-solving skills
Strong communicator and presentation skills (oral and written)
Fluent in both written and spoken English
Desirable Requirements:
RLT, CAR T or Oncology experience a plus!
The salary for this position is expected to range between $108,500 and $201,500 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Division
Development
Business Unit
Development
Location
USA
State
Field, US
Site
Field Non-Sales (USA)
Company / Legal Entity
U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
Internal job title: CRA II
Location: Remote (Texas, Louisiana, Arkansas, Oklahoma or New Mexico)
Job description
Key responsibilities: Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis)
Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
Facilitates the preparation and collection of site and country level documents
Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects and performs continuous training for amendments and new site personnel as required ensuring thorough documentation in Monitoring Visit Reports
Conducts continuous monitoring activities (onsite and/or remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety.
Accountable for continuously updating all relevant electronic systems to perform job functions
Takes on the responsibility as SME (Subject Matter Expert) as needed
Monitors studies as per current legislations, ICH/GCP and Novartis standards
Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring.
Identifies, resolves & escalates issues appropriately
Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry
Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as well as Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to achieve key accountabilities
Partners with SSU CRA to ensure seamless transition of site responsibility
Essential Requirements:
Minimum of 3 years’ experience in site monitoring
BS/BA degree. Scientific, Healthcare or other related field.
Excellent knowledge of the drug development process specifically clinical trial/research
Knowledge of international standards (GCP/ICH, FDA, EMEA)
Ability to manage multiple priorities and manage time efficiently.
Excellent Site management capabilities with demonstrated negotiating and problem-solving skills
Strong communicator and presentation skills (oral and written)
Fluent in both written and spoken English
Desirable Requirements:
RLT, CAR T or Oncology experience a plus!
The salary for this position is expected to range between $108,500 and $201,500 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Division
Development
Business Unit
Development
Location
USA
State
Field, US
Site
Field Non-Sales (USA)
Company / Legal Entity
U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
