Job Description

GENERAL SUMMARY/ OVERVIEW STATEMENT: Summarize the nature and level of work performed.

The Clinical Research Coordinator II (CRC II) will support The Massachusetts General Hospital Epilepsy Service. The CRC II is responsible for assisting clinical research projects focusing on the management of patients with seizure disorders and epilepsy.

PRINCIPAL DUTIES AND RESPONSIBILITIES: Indicate key areas of responsibility, major job duties, special projects and key objectives for this position. These items should be evaluated throughout the year and included in the written annual evaluation.

- Maintaining and overseeing regulatory documentation for research studies

- Preparing IRB applications and amendments

- Management and possible analysis of radiology imaging and electrophysiology EEG data in the context of research studies

- Educating staff as new projects are launched, preparedness to speak and explain projects in a meeting setting

- Subject Recruitment, Informed Consent, Study Visit Management, and interaction with sponsors, CROs, and CRAs for research studies

- Sample tracking and inventory upkeep

- Inputting, manipulating, and maintaining information in clinical research databases

- Assist in preparation of manuscripts resulting from data generated research projects

- Administration and facilitation of clinical research projects based in the Epilepsy Service at MGH

- Recruitment of outpatient and inpatient study subjects.

- Interacting with sponsors, CRAs, CROs, and data management personnel

- Ongoing administration and analysis of clinical tools including standardized surveys and inventories measuring mood, attention and cognitive function

- Support of lab sample processing activities as needed

- Support of data and database requests and analysis as needed

- Participation in manuscript development and publication with opportunity for authorship.

SKILLS/ABILITIES/COMPETENCIES REQUIRED: Must be realistic, objective, measurable and related to essential functions of this job.

- Ability to handle sensitive and confidential information.

- Excellent time management skills, as project timelines and stages vary

- Comfortable interacting with physicians, nurses, patients and their families

- Familiarity with basic data analysis software is preferred (e.g., Excel, Access, SPSS, SAS, STATA)

- Knowledge of standard laboratory techniques

- Knowledge of safe sample handling procedures

- Ability to learn how to use specialized lab and monitoring equipment

- Ability to focus, work independently, and to regularly seek feedback

- Ability to establish priorities, balance demands of multiple projects, and meet deadlines

- Careful attention to details.

- Excellent organizational & communication skills (articulate with good writing and phone skills)

- Working knowledge of data management programs

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable): Specify minimum credentials and clearly indicate if preferred or required

N/A

Qualifications

EDUCATION: Specify minimum education and clearly indicate if preferred or required

- BA/BS degree required

EXPERIENCE: Specify minimum creditable years of experience and clearly indicate if preferred or required

- 1 year of experience in clinical research.

- Background in information technology, computer science, or signal processing is preferred, but not required

SUPERVISORY RESPONSIBILITY (if applicable): List the number of FTEs supervised.

N/A

FISCAL RESPONSIBILITY (if applicable): Indicate financial \xe2\x80\x9cscope\xe2\x80\x9d information, i.e.: size of budget, volume, revenue, etc.; Indicate total physician/non-physician FTE scope

N/A

WORKING CONDITIONS: Describe the conditions in which the work is performed.

- Office and clinic environment at MGH Main Campus

- Must be able to travel between hospital and research buildings carrying study documents and materials.

Mass General Brigham