Clinical Trial Protocol & Qual Analyst
Dartmouth College - New Hampshire

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Seeking applicants for our Clinical Trial Protocol and Quality Analyst position who possess a Bachelor's degree (preferably in Health Sciences), and have 3 to 5 years of relevant experience in clinical trials research support (preferably as a research coordinator), experience with industry sponsored, federally sponsored, and investigator-initiated clinical research and experience with medical coding and electronic medical record systems preferred. Professional certification as a clinical research coordinator preferred. A successful candidate will have expert knowledge of clinical trials design, scientific analysis, and trend analysis--preferably in oncology; skill in reading and interpreting experimental protocols; knowledge of GCPs and federal regulations related to human subject research--especially research using investigational new drugs; and knowledge of medical terminology, diagnostic and treatment modalities in oncology and hematology (preferred). Knowledge of patient privacy and confidentiality regulations and policies is essential in order to maintain extremely professional standards handling highly sensitive and confidential issues. Candidate must be an experienced, independent decision maker who utilizes good judgment and has proven communication skills, particularly regarding sensitive information- including technical report writing. Our final candidate will demonstrate strong organizational skills and meticulous attention to detail and confidentiality of data. Must also have the ability to balance and prioritize competing demands, adjust to changing deadlines and make decisions under deadline pressures. Further, we are seeking a team member with a wide range of computer application experience.

Position Purpose:
Coordinates all aspects of the NCI required NCCC Clinical Cancer Research Committee (CCRC), the NCCC Population Research Scientific Review Committee (PRSRC), and the Data Safety and Accrual Committee (DSMAC). Provides activation support for PIs developing investigator initiated (IIT) clinical trial protocols including protocol, editing and navigation through the study activation review processes. Conducts required clinical trial quality reviews critical to assuring patient safety and compliance with federal regulations and institutional policies.Independently determines research protocol and regulatory compliance adherence and reports to appropriate institutional officials.

Skills & Knowledge:
Expert knowledge of clinical trials design, scientific analysis, and trend analysis; preferably in oncology. Skill in reading and interpreting experimental protocols. Knowledge of GCPs and federal regulations related to human subject research, especially research using investigational new drugs. Knowledge of medical terminology, diagnostic and treatment modalities in oncology and hematology preferred. Knowledge of patient privacy and confidentiality regulations and policies. Maintains extremely professional standards handling highly sensitive and confidential issues. Experienced independent decision maker who utilizes good judgment and has proven communication skills, particularly regarding sensitive information; including technical report writing. Strong organizational skills. Meticulous attention to detail and confidentiality of data. Ability to balance and prioritize competing demands, adjust to changing deadlines and make decisions under deadline pressures. Demonstrated experience with a wide range of computer applications.

Minimum Experience:
Three to five years of relevant experience in clinical trials research support, preferably as a research coordinator Experience with industry sponsored, federally sponsored, and investigator initiated clinical research. Experience with medical coding and electronic medical record systems preferred

Minimum Education:
Bachelors degree, preferably in the Health Sciences. Professional certification as a clinical research coordinator preferred

FLSA:
Exempt

Level:
DRM D

Employment Category:
Regular Full Time

Link to Position Description: Not available for faculty positions

Click Here for Description

Contact name of the individual who will be receiving/viewing the resumes,cover letters, etc.

Ms. Rebecca Rogers, MA, CIP

Special Instructions to Applicants:
This position is located at Dartmouth-Hitchcock Medical Center, which is a Smoke-Free Facility. Employment in this position is contingent upon consent to and successful completion of a pre-employment background check, which may include a criminal background check, reference checks, verification of work history, and verification of any required academic credentials, licenses, and/or certifications, with results acceptable to Dartmouth College. A criminal conviction will not automatically disqualify an applicant from employment. Background check information will be used in a confidential, non-discriminatory manner consistent with state and federal law.

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