Your tasks and responsibilities
The primary responsibilities of this role, Senior Clinical Research Associate, are to:
Who you are
- Be 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;
- Manage Investigator sites and site activities and monitor 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;
- Manage Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out;
- Conduct Site Selection Visits to confirm the Investigator and Site Staff are qualified, and have suitable resources and facilities to properly conduct the study;
- Ensure completion of site documents necessary for ethics and regulatory approval for site initiation within agreed upon timelines. Ensure all legal, regulatory and Bayer requirements are met prior to drug shipment to sites as well as all site initiation processes are completed;
- Ensure Investigator Agreements and budgets are negotiated and executed for assigned study sites, and subsequently initiating payments at key milestones;
- Train and supervise cross functional site personnel on study related procedures for the duration of the study;
- Track to ensure sufficient resources at site to conduct study activities for duration of the study;
- Track enrollment activities to ensure site remains on track with site commitments. Develop contingency plans to ensure site commitments 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;
- Assure adequate control of investigational product (study medication), which includes: ensuring sites have met all local and legal requirements to receive investigational product, study drug storage, and continually ensuring patient compliance with expected study drug dosing;
- Be responsible for study drug accountability at the site level and arrange for destruction of investigational product in accordance with local legal and regulatory requirements;
- Ensure applicable authorities are notified of study closure and final patient status in accordance with ICH and local regulations;
- Periodically review Investigator Site File to ensure essential documents are maintained according to ICH and SOP requirements;
WHO YOU ARE
- Adhere to the rigorous regulatory guidelines that exist to ensure overall patient safety related to reporting of serious or unexpected adverse drug reactions. Also be responsible for training the Investigator and site staff on these strict regulations and procedures 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;
- Proactively identify potential issues and develop site Corrective Actions / Preventive Actions (CAPAs) Plans and ensure timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data;
- Ensure essential documents are appropriate and filed in a timely manner in the Investigator Site File as a key contributor to the Trial Master File and study documents at the country level;
- Be a key contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome;
- Be a member of the audit/regulatory inspection team;
- Mentor and role model for new or less experienced CRAs on process, study, technical or 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. In addition, the Sr CRA may participate in Expert Working Groups for Global SOPs (standard operating procedures), training or process improvement initiatives.
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;
- Six to seven (6-7) years of relevant healthcare experience;
- Four (4) years of monitoring and site management experience;
- Experience in Oncology studies;
- In-depth knowledge of the drug development process including monitoring and site management, local and international regulations, ICH-GCP, drug safety requirements, data management processes and investigator grant parameters;
- Awareness and understanding of cultural differences as well as regional operational differences and budge management;
- Effective written and verbal English communication skills, strong oral presentation; interpersonal, decision making and issue resolution skills;
- Effective planning and organization skills, attention to detail and excellent follow through.
- Experience in Phase 1 Oncology studies.
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:
PA-York, PA-West Chester, PA-Pittsburgh, PA-Allentown, DE-Dover, NY-Albany, Residence Based, PA-Warrendale, NY-Commack, NY-Garden City, NY-Long Island, PA-Lancaster, NY-Buffalo, PA-Philadelphia, PA-Wilkes Barre, PA-Scranton, NY-Brooklyn, PA-Norristown, PA-Bensalem, PA-Drexel Hill, DE-Wilmington, Residence Based, NY-Newburgh, NY-Bronx, NY-Syracuse, NY-White Plains, PA-Harrisburg, PA-Pittsburgh Heilman, PA-Saxonburg, Residence Based, NY-Tarrytown, NY-Rochester, Residence Based, PA-Reading, PA-Indianola, PA-Myerstown, NY-Staten Island, NY-Manhattan, NY-Queens, PA-Pottstown
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.