Clinical Trial Assistant- Monitoring

• Aug 2021 - Present

As a Clinical Trial Assistant (CTA) I have to assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. To assist project teams with study specific documentation and guidelines as appropriate. As a Clinical Trial Assistant (CTA) I have to assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. To assist project teams with study specific documentation and guidelines as appropriate.

Consultant- CRC

• Nov 2020 - Aug 2021

Overseeing the smooth running of clinical trials. Collecting, coding, and analyzing data obtained from research. Managing research budgets. Informing participants about study objectives. Administering questionnaires. Monitoring research participants to ensure adherence to study rules. Adhering to research regulatory standards. Adhering to ethical standards. Maintaining detailed records of studies as per FDA guidelines, including things such as drug dispensation. Liaising with laboratories regarding findings. Participating in subject recruitment efforts. Ensuring that the necessary supplies and equipment for a study are in stock and in working order. Engaging with subjects and understanding their concerns. Show less

Sr CRC

• Dec 2019 - Nov 2020

General Administrative :- Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and university and sponsoring agency policies and procedures. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training. Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures. Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors. Collaborates with PI and institution to respond to any audit findings and implement approved recommendations. Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office. Conduct of Research :- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log. Show less

Clinical Research Coordinator

• Nov 2018 - Nov 2019

IPD- Pharmacist

• Sep 2015 - Sep 2017