Senior Clinical Research Associate

  • Bayer
  • $64,190.00 - 83,300.00 / Year *
  • Full-Time



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Senior Clinical Research Associate



Your tasks and responsibilities







The primary responsibilities of this role,Senior
Clinical Research Associate, are to:







Key Tasks:





+ Due to the increased scrutiny of regulatory authorities on the
quality of clinical trial data, and increased business demands to
conduct clinical trials in an efficient manner, the focus of the
Senior Clinical Research Associate (CRA) and CLM position is
strengthened to reflect greater focus on quality and oversight and
achieving commitments;



+ Senior CRA is accountable and responsible for:







+ All aspects of site management and monitoring activities for
assigned applicable Phase I and all Phase II-IV clinical
Investigator sites within the approved Clinical Development Plan
(CDP);



+ These global, complex studies are conducted within the
standards set by Bayer Global;







+ Development, according to Good Clinical Practices (ICH - GCP)
and applicable regulatory and legal requirements;



+ Managing Investigator site and site activities and monitoring
site data, to ensure patient safety and ethical and regulatory
compliance necessary to provide quality data required for global
regulatory submissions for approval of drugs;



+ Managing Investigator site to ensure the Investigator and Site
Staff meet all aspect of study delivery and commitment to make
certain the operational study execution is on track from site
selection to site close out;



+ Conducting Site Selection Visits to confirm the Investigator
and Site Staff are qualified, and have suitable resource and
facilities to properly conduct the study;



+ Ensuring completion of site document necessary for ethic and
regulatory approval for site initiation within agreed upon
timeline;



+ Ensuring all legal, regulatory and Bayer requirements are met
prior to drug shipment to sites as well as all site initiation
processes are completed;



+ Ensuring Investigator Agreement and budget are negotiated and
executed for assigned study sites, and subsequently initiating
payments at key milestones;



+ Training and supervising cross functional site personnel on
study related procedures for the duration of the study;









Who you are





+ Tracking to ensure sufficient resource at site to conduct study
activities for duration of the study;



+ Tracking enrollment activities to ensure site remains on track
with site commitments;



+ Develop contingency plan to ensure site commitment are
met;



+ Review patient data at site to ensure safety of patient and
patient data is consistent with what is reported in the case report
form;



+ Serve as liaison between Investigator and Study Medical Expert
to resolve any medical patient-related queries;



+ The data from these clinical sites are required to demonstrate
patient safety and efficacy of investigational products which forms
the basis of regulatory approval;



+ Assuring adequate control of investigational product (study
medication), which includes: ensuring sites have met all local and
legal requirement to receive investigational product, study drug
storage, and continually ensuring patient compliance with expected
study drug dosing;



+ The Sr. CRA is responsible for study drug accountability at the
site level and arrange for destruction of investigational product
in accordance with local legal and regulatory requirements;



+ Ensuring applicable authorities are notified of study closure
and final patient status in accordance with ICH and local
regulation;



+ Periodically review Investigator Site File to ensure essential
documents are maintained according to ICH and SOP requirement;



+ Rigorous regulatory guideline exist to ensure overall patient
safety related to reporting of serious or unexpected adverse drug
reactions;



+ The Sr. CRA is responsible for training the Investigator and
site staff on these strict regulation and procedure for timely
reporting and as well as monitoring ongoing compliance;



+ Strict adherence is essential to remain compliant with on time
reporting from Bayer to regulatory authorities and critical for
thorough and timely evaluation of patient safety;



+ Due to the highly regulated clinical trial environment, the Sr
CRA proactively identifies potential issue and develop site
Corrective Actions / Preventive Actions (CAPA) Plan;



+ The Sr CRA ensure timely and sufficient resolution of issues
that may impact compliance or quality of study related activities
or data;



+ As key contributor to the Trial Master File and study documents
at the country level, ensure essential document are appropriate and
filed in a timely manner in the Investigator Site File;



+ Incumbent is a key contributor in the preparation, conduct and
follow up of Site Audits and Regulatory Inspections to ensure a
successful outcome;



+ The Sr. CRA is a member of the audit/regulatory inspection
team;



+ Due to experience and expertise, the Sr CRA may be a mentor and
role model for new or less experienced CRAs on process, study,
technical or behavioral competencies;



+ The Sr CRA may also conduct co-monitoring visits as defined in
the Study Oversight Plan to mitigate risk and ensure the quality
and reliability of study data and processes;



+ In addition, the Sr CRA may participate in Expert Working
Groups for Global SOPs, training or process improvement
initiatives;



+ Country Lead Monitors (CLM) is accountable and responsible to
ensure consistency, quality and efficiency across the Country
CRA Study Team, a CLM is assigned for every participating country
and is responsible for and oversees the CRAs and study progress at
the country level from study feasibility to study archive;



+ Require significant country cross functional collaboration
throughout the study conduct.









WHO YOU ARE







Your success will be driven by your demonstration of our LIFE
values. More specifically related to this position, Bayer
seeks an incumbent who possesses the following:







Required Qualifications:





+ The incumbent must have a Bachelor's Degree with 6
- 7 years of healthcare experience including 4 years of
monitoring & site management experience;



+ The incumbent is responsible for site management and monitoring
of applicable Phase I and all Phase II-IV complex and global
clinical trial;



+ This require an in-depth knowledge of the drug development
process including monitoring and site management, local and
international regulation, ICH - GCP, drug safety requirement,
data management processes and investigator grant parameter;



+ The position also require awareness and understanding of
cultural difference as well as regional operational differences and
budget management;



+ Effective written and verbal English communication skills,
strong oral presentation, interpersonal, decision-making and issue
resolution skills are required;



+ In addition, the incumbent requires effective planning and
organization skills, attention to detail and excellent follow
through.









Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the \"Passion to Innovate\" and the \"Power to Change\", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.













Bayer is an Equal Opportunity Employer/Disabled/Veterans







Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

















Country:United States

Location:Residence Based, NJ-Whippany

Functional Area:

Entry Level:
Associated topics: alcohol test, assay, equipment, laboratory technologist, lab technician, lab technologist, qa, quality, research, research associate


* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.