Clinical Research Specialist

Job Description

Job ID: 22037
Date Posted: 01/17/2012
Location: 450 Brookline Ave
Job Family: Research
Full/Part Time: Full-Time
Regular/Temporary: Regular
FLSA Status: Exempt

Job Summary

Located in Boston, MA, Dana Farber Cancer Institute, a Comprehensive Cancer Center designated by the National Cancer Institute, an affiliate of Harvard Medical School,is committed to providing expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment cure, and prevention of cancer and related diseases.

GENERAL SUMMARY: The Clinical Research Specialist for the Center for Neuro Oncology performs, coordinates, and monitors all aspects of the regulatory process within clinical trials in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols. Conducts site visits to determine protocol and regulatory compliance, and prepares required documentation. Responsible for multiple projects and must work both independently and in a team environment. May participate in protocol and study development and start up processes including reviewing protocols, designing and/or reviewing Case Report Forms, preparing informed consent documents, developing study specific source document worksheets, and working with study team management on operational strategies.

PRIMARY DUTIES AND RESPONSIBILITIES: (List 5-8 items)

Assist in the development and writing of clinical trial protocols.
Liaise with investigators and disease groups on conducting clinical trials.
Prepare and manage regulatory applications to federal and local agencies (FDA, OHRS, etc.) and the related approval process.
Locate and/or assess the suitability of study sites to conduct clinical trials.
Monitor trial progress throughout its duration which may include visiting study sites on a regular basis.
Verify that data entered on the Case Report Form is consistent with patient clinical notes and other source documentation (source data verification).
Act as a regulatory resource for study sites by maintaining regular contact with investigators and study teams during the course of studies to ensure that compliance is maintained.
Prepare reports as required regarding the status of ongoing studies and make necessary recommendations for contingency planning.

SUPERVISORY RESPONSIBILITIES: No direct supervisory responsibilities.

Job Qualifications

MINIMUM JOB QUALIFICATIONS: (Education, certifications, years of experience)

BS/BA degree required; Masters preferred. Minimum of 5 years clinical research experience with oncology background preferred.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

Requires excellent verbal and written communication skills with an in-depth knowledge of GCP guidelines, medical terminology, and the clinical trial process. In addition, excellent interpersonal skills with strong organizational skills and an attention to detail are needed. Must be computer literate and be able to travel depending on project needs.

PATIENT CONTACT: No direct patient contact required.

DISCLAIMER: The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an at will employment relationship.

Clinical Research Specialist

Job Description

Employment Type