"Clinical Research Analyst 2"

Overview

Under the general guidance of the Department of Obstetrics, Gynecology and Reproductive Sciences’ Maternal-Fetal Medicine Division Chief and the Director of Reproductive/Placental Research Unit, responsible for directing and managing all clinical ultrasound studies. Responsible for ensuring competency of staff across the research program through ongoing training programs, coaching and mentoring. Ensure compliance with the clinical research operations. Develops and implements process improvement initiatives to meet goals and objectives. Oversees all activities necessary to ensure effective and timely activation of clinical research from the stage of protocol concept, IRB submission through recruitment and follow-up. Conducts ultrasound clinical research on study/hospital subjects in compliance with study protocol requirements. Ensures all protocol requirements are followed and appropriately documented. Performs research ultrasounds in accordance with clinical trials study requirements. Contributes scientifically to the writing of reports, abstracts and manuscripts related to these clinical trials.

Serves as resource in interpreting protocols and communicating to patients and relevant staff. Trains others on specific clinical research protocols in conjunction and in collaboration with investigators. Responsible for subject recruitment, enrollment and all related documentation involved in the study participation. Performs research prenatal ultrasounds on patients and obtain measurements on the obtained images. Keeps detailed records of patient visits per study guidelines. Collects relevant clinical information from study/hospital subjects, either by direct interactions and/or via medical records.

Required Skills and Abilities

1. Strong knowledge of clinical trial research studies with ability to explain, clarify and teach study contents.
2. Proven experience performing research ultrasounds in both clinical and research settings.
3. Strong understanding of IRB policies/procedures.
4. Excellent communication skills with patients, faculty and trainees.
5. Ability to communicate and successfully interact with staff, other sonographers, and health care providers in a clinical/research setting.

Preferred Skills and Abilities

1. Master’s degree in health services management or related field.
2. Medical Sonography certification or equivalent to 15 years or more of sonography experience.

Principal Responsibilities

1. Works closely with investigators and other study team members including the project manager, for projects or programs of a medium to large scope to consult, conduct analysis, and identify trial objectives and requirements.
2. Interprets research business needs and translates them into application and operational requirements. Develops necessary tools and workshops to successfully elicit requirements.
3. Critically evaluates information gathered from multiple sources - research protocols, clinical trial agreements, financial budgets and fees associated with research - to reconcile conflicts, and decompose high-level information into data essentials.
4. Receives and interprets requests for data extracts, analyses, and reports. Develops reporting modules, ad-hoc reports, and related reporting tools. Conducts research, data gathering, data analysis, modeling, projecting and scenario analyses, with the aid of planning technology and databases. Develops and harnesses the data that is available to identify existing business issues and key drivers and develops solutions and initiatives.
5. Analyzes data with standard statistical methods, interprets the results, and provides written summary and reporting of data analysis.
6. Develops, validates, deploys, implements, and maintains queries for the successful extraction of appropriate data.
7. Develops and maintain documentations and libraries on key processes.
8. Assesses risk and ensures compliance with research protocols/guidelines and university procedures.
9. Determines training needs, designs, develops and conducts training sessions, meetings and conference calls with study teams and staff members.
10. Collaborates with developers and subject matter experts to establish the technical vision and analyze tradeoffs between usability and business needs. Ensures strategic and tactical plans are carried out.
11. Communicates effectively the perspective of business opportunities, needs, and risks.

Required Education and Experience

Six to eight years of related work experience in the same job family and a Bachelor’s Degree in a related field; or an equivalent combination of education and experience.

Salary Range

$68,000.00 - $120,500.00

Location

310 Cedar Street, New Haven, Connecticut