Your tasks and responsibilities
CRA II is accountable and responsible for:
1. 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
2. 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.
3. Managing 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.
a. Conducting Site Selection Visits to confirm the Investigator and Site Staff are qualified, and have suitable resources and facilities to properly conduct the study.
b. Ensuring completion of site documents necessary for ethics and regulatory approval for site initiation within agreed upon timelines. Ensuring all legal, regulatory and Bayer requirements are met prior to drug shipment to sites as well as all site initiation processes are completed.
c. Ensuring Investigator Agreements and budgets are executed for assigned study sites, and subsequently initiating payments at key milestones.
d. Training and supervising cross functional site personnel on study related procedures for the duration of the study.
Who you are
g. Tracking enrollment activities to ensure site remains on track with site commitments. Develops contingency plans to ensure site commitments are met.
h. Reviewing patient data at site to ensure safety of patient and patient data is consistent with what is reported in the case report form. Serves 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.
i. Assuring 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. The CRA II is responsible for study drug accountability at the site level and arranges for destruction of investigational product in accordance with local legal and regulatory requirements.
j. Ensuring applicable authorities are notified of study closure and final patient status in accordance with ICH and local regulations.
k. Periodically reviews Investigator Site File to ensure essential documents are maintained according to ICH and SOP requirements.
4. Rigorous regulatory guidelines exist to ensure overall patient safety related to reporting of serious or unexpected adverse drug reactions. The CRA II is responsible for training the Investigator and site staff on these strict regulations and procedures for timely reporting and as well as ensuring ongoing compliance. Strict adherence is essential to remain complaint with on time reporting from Bayer to regulatory authorities and critical for thorough and timely evaluation of patient safety.
5. Due to the highly regulated clinical trial environment, the CRA II proactively identifies potential issues and develops site Corrective Actions / Preventive Actions (CAPAs). The CRA II ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
6. As key contributor to the Trial Master File and study documents at the country level, ensures essential documents are appropriate and filed in a timely manner in the Investigator Site File.
7. Incumbent is a key contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome. The CRA II is a member of the audit/regulatory inspection team.
The incumbent must have a Bachelor’s Degree (or
equivalent) with 4-6 years of relevant healthcare experience
including 2 - 3 years of monitoring & site management
The incumbent is responsible for site management and monitoring of applicable Phase I and all Phase II-IV complex and global clinical trials. This requires an in-depth knowledge of the drug development process including monitoring and site management, local and international regulations and international regulations, ICH – GCP, drug safety requirements, data management processes and investigator grant parameters. The position also requires awareness and understanding of cultural differences as well as regional operational differences. 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.