Clinical Research Associate

Job Profile Summary

This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes.

In addition, this role focuses on performing the following Research Programs and Projects duties : Supports the development of new products and innovation.

Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and / or clinical research towards solving a specific problem for an entity or community.

A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs.

The majority of time is spent overseeing the design, implementation, or delivery of processes, programs, and policies using specialized knowledge and skills typically acquired through advanced education.

An experienced level role that applies practical knowledge of job area typically obtained through advanced education and work experience.

Works independently with general supervision; problems faced are difficult but typically not complex, and may influence others within the job area through explanation of facts, policies, and practices.

Job Overview

This position is responsible for the development, implementation, management, and administration of clinical trial protocols.

Interfaces with federal and corporate sponsors, inpatient and outpatient facilities, departments, and personnel to assure a collaborative environment and high-quality outcomes.

Coordinates and delivers patient care.

Minimum Qualifications :

1. Bachelor's degree in clinical area.

2. Appropriate licenses, certifications, and / or registrations related to clinical training.

Preferred Qualifications :

1. Experience with clinical trials.

2. Experience in inpatient and outpatient healthcare delivery.

Duties and Responsibilities : The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list.

Other duties and responsibilities may be assigned.

1. Reviews proposed protocols with the Principal Investigators to assess the feasibility of undertaking the project.

2. Assists in preparation of initiating documentation, budget preparation, and resource and personnel allocation, and consent form creation.

3. Works as a liaison with IRB to facilitate approval of projects and ongoing documentation and reporting.

4. Liaisons with sponsor agency and monitoring personnel.

5. Interacts with PI and collaborating physicians, inpatient and outpatient facilities, and personnel to comply with study protocols and requirements.

6. Coordinates and manages patient recruitment, monitoring, and documentation of care and progress.

7. Provides direct patient care including interviewing to obtain relevant historical, medical personal, and physical data for patient data collection forms.

8. Collects specimens and prepares, handles, stores, and mails as necessary for various protocols.

9. Records test results accurately and timely, inpatient hospital records, case report forms, and MD's own record (clinic charts).

10. Provides patient information, instruction in written and verbal form in patient diary, keeping medication usage and protocol compliance.

11. Maintains collaborative, team relationships with peers and colleagues in order to effectively contribute to the working group's achievement of goals, and to help foster a positive work environment.

Physical Requirements :

1. This is largely a sedentary role, which involves sitting most of the time, but may involve movements such as walking, standing, reaching, ascending / descending stairs, and operating office equipment.

2. Frequently required to speak, hear, communicate, and exchange information.

3. Ability to see and read computer displays, read fine print, and / or normal type size print and distinguish letters, numbers, and symbols.

4. Requires manual dexterity using fine hand manipulation to operate computer keyboard.

Skills & Abilities :

1. High degree of organizational talents, data collection, and analysis skills.

2. Requires meticulous attention to detail.

3. Excellent computer skills including word processing.

4. Ability to prioritize quickly and appropriately.

5. Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, and sponsors.

6. Care in organization and systematic record-keeping.

The experience expected from applicants, as well as additional skills and qualifications needed for this job are listed below.

Tufts Medicine is a leading integrated health system bringing together the best of academic and community healthcare to deliver exceptional, connected, and accessible care experiences to consumers across Massachusetts.

Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.

We are an equal opportunity employer and value diversity and inclusion at Tufts Medicine. Tufts Medicine does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and / or expression, marital status or any other characteristic protected by federal, state or local law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation by emailing us at [email protected].

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