Clinical Research Associate II
Your tasks and responsibilities
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 legal requirements.
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 meetall 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
c. Ensuring Investigator Agreements and budgets are negotiated and
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.
e. Continuously assessing site performance, processes,
Who you are
and local legal requirements, as well as ICH-GCP.
f. Tracking to ensure sufficient resources at site to conduct
study activities for duration of the study.
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
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
j. Ensuring applicable authorities are notified of study closure
and final patient status in accordance with ICHand local regulations.
k. Periodically reviews Investigator Site File to ensure essential
documents are maintained according to ICH and SOP requirements.
4. Rigorous regul