YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Senior Clinical Research Associate (SR CRA), are to:
- Provide adequate site resources for conduct of the study including staff, facilities, and equipment;
- Provide proper training and qualifications for all site staff participating in the study;
- Be on charge of the proper control, storage, dispensation, patient compliance, and accountability of Investigational Product;
- Ensure appropriate Regulatory and Legal approvals are in place throughout the conduct of the study;
- Ensure site enrollment commitments are on track with enrollment plan;
- Ensure data integrity, quality, and timely resolution of all queries.
- Be on charge of documentation and timely resolution of all action items which could negatively impact study deliverables;
- Ensure that all adverse events (AEs) are appropriately reported within the time periods required by Good Clinical Program (GCP), the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s);
- Prepare and conduct onsite and/or remote monitoring visits according to monitor plan, including complete reporting and follow up for all monitoring visits;
- Be responsible for training the investigator and site staff on the strict regulations and procedures for timely reporting as well as monitoring ongoing compliance;
- Identify potential issues and assist the project team in the development of site Corrective Action/Preventative Action Plans (CAPAs) if required.
- Ensure timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data;
- Act as a key contributor to the paper or electronic Trial Master File (TMF) and study documents at the country and site level;
- Ensure essential documents are appropriate and filed in a timely manner in the Investigator Site File with an expectation to be inspection ready at all times;
- Act as a member of the audit/regulatory inspection team and a key contributor in the preparation, conduct, and follow-up of site audits and regulatory inspections to ensure a successful outcome;
- Be a mentor and role model for new or less experienced CRAs on process, study, technical, and behavioral competencies;
- Conduct co-monitoring visits as defined in the Study Oversight Plan to mitigate risks and ensure the quality and reliability of study data and processes;
- Participate in Expert Working Groups for Global SOPs, training or process improvement initiatives or other activities at the discretion of the CH or LM;
- Collaborate with the Country Lead Monitor (CLM) and Study Lead Monitor (SLM) for internally monitored and outsourced clinical trials;
- Ensure patient safety as well as quality and compliance of clinical trial data for Regulatory Approvals of a drug;
- Be the first contact of the company with the customer (physician, MD), and establish and maintain customer essential relationships from development of study drugs and even after they are in the market;
- Be able to take site management activities for sites which are challenging to manage, and have higher capacity to take more site assignments or take sites in complex studies;
- Contribute to trial oversight activities such as co-monitoring visits.
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:
- Bachelor's Degree in Healthcare and four years of monitoring and site management experience OR the combination of education and minimum 15 years' relevant healthcare experience including a minimum of ten years' site management and monitoring experience;
- Awareness and understanding of cultural and regional operational differences;
- Oral presentation and interpersonal skills;
- Decision making;
- Issue resolution;
- Planning and organization, time management, prioritization;
- Effective written and verbal English communication skills;
- Travel to sites, study meetings, local and international level up to 80%.
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. 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.
Location: United States : Residence Based : Residence Based
Reference Code: 68385
- 1 888-473-1001, option #5