Clinical Research Associate

Georgetown University•Vinalhaven, ME

4d•Onsite

About The Position

The candidate will provide clinical and research services to clinical trial subjects participating in Infectious Diseases studies under the supervision and direction of Dr. Princy Kumar. The incumbent must be able to manage and coordinate complex COVID-19 studies in accordance with established protocols and guidelines. This position is responsible for monitoring and screening patients and administering investigational therapies for all clinical trials. The incumbent should exhibit a high level of clinical skills and the ability to make decisions in response to unique clinical situations. The Clinical Research Associate works directly with clinical trial subjects. Will provide professional care for patients following established standards and practices, order and interpret diagnostic test. The incumbent will also complete all study related documentation and ensure that standard clinical procedures and protocol regulations are met. Additional duties include, but are not limited to: Maintains a robust understanding of research processes Partners with clinical staff to help with documentation and data requirements of research functions Interact with the Clinical Trial Office, Pharmacy, Clinical Research Coordinators, Financial Administrator, and Regulator Specialists Monitoring and screening of patients and administering investigational therapies under close supervision of Principal Investigator and Co-Investigators Effectively communicates with trial subjects, internal resources and support teams to ensure objectives are met and regulatory compliance is maintained Collaborates with clinical and research resources to identify and develop process improvements Participates in cross functional teams to gather clinical and research needs in order to identify effective solutions.

Requirements

Knowledge of professional nursing theory and practices to assess, plan, implement, and evaluate patient care.
Bachelor's degree and 5+ years of experience or equivalent relevant work experience.
Experience in research protocols and quality assurance.
Knowledge of and sensitivity to a myriad of issues related to HIV infection and COVID-19 is critical.
Ability to work in a Clinical Research setting.
Strong knowledge and familiarity of Microsoft Office applications.
Excellent problem-solving skills.
Excellent communication skills.
General knowledge of clinical research.

Nice To Haves

Master’s Degree in a related field is a plus.
Experience in a University Medical setting is helpful.
Ability to react calmly and effectively in emergency situations is preferred.
Familiarity with Infectious Diseases Clinical Trials.

Responsibilities

Provide clinical and research services to clinical trial subjects.
Manage and coordinate complex COVID-19 studies.
Monitor and screen patients.
Administer investigational therapies.
Provide professional care for patients following established standards and practices.
Order and interpret diagnostic tests.
Complete all study related documentation.
Ensure that standard clinical procedures and protocol regulations are met.
Maintain a robust understanding of research processes.
Partner with clinical staff to help with documentation and data requirements of research functions.
Interact with the Clinical Trial Office, Pharmacy, Clinical Research Coordinators, Financial Administrator, and Regulator Specialists.
Effectively communicate with trial subjects, internal resources and support teams.
Collaborate with clinical and research resources to identify and develop process improvements.
Participate in cross functional teams to gather clinical and research needs.