Senior CRA
Department Clinical Trial Management
Designation Senior Clinical Research Associate
Basic qualific ation Minimum of Bachelor of Arts or Science Degree in a related field or sufficient
required equivalent relevant training and
Experience 2 - 6 Years
Location U.S.-remote
Brief JD • Identify and qualify potential investigators to ensure that the sites have adequate time and
can
fulfill their obligation to the study.
- Responsible for identification & collection of necessary documents to be forwarded to Project
Manager/ designee, in order to check the feasibility of site/ investigator and approval from
authorities.
- Prepare or submit or support other colleagues for Regulatory and EC submissions and in the
generation of Financial Agreements according to standard and local country practices.
- Negotiate study budgets with investigators and ensure that timely payments are made to the
site as per guidance from Project Manager.
- Conduct of monitoring visits as per monitoring plan in order to check compliance with study
management, protocol & other requirements at all assigned sites.
- Responsible for training of site study team regarding the monitoring plan, recording &
maintenance of essential documents and for start up activities & site initiation as per the
guidance of Project Manager.
- Assist for the preparation and presentation at investigator meetings, as required to ensure
that
the clinical and investigational site staff team are well informed about the study and related
procedures.
- Maintaining a working copy of Central Investigator File & ensuring consistency with the Site
Investigator File in order to maintain a working record of all essential documents and reports.
- Perform source document verification as per monitoring plan and ensure that source
documents & other trial records are accurate, complete, kept up-to-date & maintained
according to applicable SOPs to avoid incomplete records.
- Ensure timely collection of documents like CRF, DCF etc from the site along with SAE reports in
order to provide Biometrics/licensing authority & others with the necessary documents.
- Responsible for study updates & Coordination with Labs & other trial related services as per
the
study requirements.
- Responsible for IP accountability and availability, tracking and management of all Clinical Trial
related supplies shipped to the sites/ warehouse & accordingly clinical trials supplies vendor
management for the study.