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Clinical Research Associate -P...

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Job Summary

Company
Anthem
Location
Watertown, MA
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4298_PS1327

Clinical Research Associate -PS1327

About the Job

Description
New England Research Institutes (NERI) was founded in 1986 and has grown to become a research organization with a global reputation for high-quality research, innovative thinking, and the use of state-of-the-science tools and techniques. NERI continues to be a leader in public health research, clinical trials management, epidemiology, and state of the art media and dissemination research.

NERI's clinical research group is one of the nation's leading scientific teams in the CRO arena, offering clients an unmatched depth of knowledge and experience. The team collaborates with sponsors in planning and conducting efficient domestic and international clinical trials and registries for the pharmaceutical and medical device industries, as well as observational studies to understand the natural history of a disease/condition or examine current standards of care.
This position may be located in Watertown, MA or remote.
The primary role of the CRA is to manage and monitor clinical sites participating in early phase clinical research studies including studies regulated by the FDA. The primary responsibilities for the position are as follows:
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Functions as the primary contact for site research staff and investigators to provide guidance; review study progress and enrollment at the site; and escalate issues to project leadership
* Collaborates with project managers and others in the development of study documents, case report forms, site staff training and procedure manuals
* CRA should be familiar with all project specific tools, such as the CTMS, Electronic Data Capture EDC and project plans in order to provide guidance and oversight to the sites
* Prepares and conducts training of new site staff
* Conducts remote and/or on-site Site Qualification Visits (SQV) and Site Initiation Visits (SIV)
* Conducts on-site routine/interim monitoring visits (IMV) to clinic sites and local/central laboratories to assess protocol compliance, SOP and GCP adherence, interview site research staff, retrain staff as needed, review regulatory documents, monitor pharmacy records, and conduct source document verification
* May conduct remote monitoring visits to verify EDC data with source documents
* Collect and review required regulatory documents and maintain Site Master Files (SMF) from site start-up through closeout
* Manage difficult sites or trouble shoots issues with underperforming sites
* Assist data management staff with the resolution of data queries
* Assist Medical Monitor in obtaining source documents related to adverse events; assist with the preparation of safety reports for the FDA and other regulatory bodies for IND trials
* Conduct on-site and/or remote closeout visits (COV)
* Write visit reports for all site visits conducted and follow up on all action items/CAPAs
Qualifications
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duties satisfactorily with regular and reliable attendance. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE
* BS or RN and 2 years of clinical research experience, some of which includes on-site clinical research monitoring experience
* Demonstrated core understanding of medical terminology, medical records and clinical trial activities;
* Must have working knowledge of ICH-GCP guidelines, and FDA regulation as a result of clinical research experience;
* Must be able to travel at least 50%;
* Ability to monitor and coordinate multi-site research trials;
* Excellent communication, interpersonal, decision making/problem solving and organizational skills;
* Ability to work independently to initiate and implement appropriate quality control procedures;
* Proficiency with Microsoft Office Products and electronic data capture (EDC) systems;
* SOCRA or ACRP certificate is helpful, but not required.
KNOWLEDGE, SKILLS AND ABILITIES
Ability to work independently and to initiate and implement appropriate quality control procedures and to monitor and coordinate multisite research trials. Excellent oral and written communication skills. Ability to travel may be required for some positions.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit, operate computer keyboard and/or other controls requiring manual dexterity verbally communicate with others and hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

In addition to a dynamic work environment, HealthCore offers a competitive salary and a comprehensive benefits program, including a 401(k) plan; health, dental, and vision insurance; discounted fitness club membership; life, AD&D, short and long-term disability insurance coverage; tuition assistance, paid parking, and an employee stock purchase plan.
HealthCore is headquartered in Wilmington, DE, midway between New York City and Washington, DC, with offices in Andover, and Watertown MA, and Alexandria, VA. As an independently operating subsidiary of Anthem, Inc., HealthCore offers the resources of the nation's leading health benefits company in a small company environment. To learn more about us or apply for a position, please visit www.healthcore.com. EOE/M/F/Disability/Veteran



 

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