Description
The Clinical Research Associate I monitors all aspects of clinical research trial(s) Clinical study life-cycle responsibilities including site management, ongoing maintenance and closure of pre-clinical, Phase I through Phase IV, and post-marketing studies.

Responsibilities

• Prepares and completes critical study documents and performs final editing/proofing prior to publishing (e.g. protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; statement of work laboratory, other vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.).
• Monitors resources/reports to deliver milestones on time and budget.
• Collect, reviews and files all clinical study documentation for assigned trial(s) and investigative sites and maintenance of clinical trial master file (CTMF): assures all documentation is maintained in compliance with all applicable guidelines and corresponding SOPs.
• Participates, with the CTM, in the preparation and hosting of clinical study team meetings on an established schedule, providing agenda, recording/distributing of minutes and copying of minutes to CTM.
• Works with the CTM to prepare and compile materials for clinical study conduct and reference information for study sites provided to the site in the form of an investigator site file (ISF).
• Prepares, collects and archives all study related correspondence to the investigator site including, but not limited to, newsletters, Dear Dr. letters, FDA/HA correspondence, contractual agreements and others.
• Responsible for investigator recruitment and maintaining current contact information for each assigned investigator site, as well as preparing investigator site file for participation approval.
• Collects pre-study documentation and essential regulatory documents from assigned investigator sites, as well as, collects updated documents prior to study initiation and on an ongoing basis.
• Estimates, orders and coordinates shipments of clinical study supplies to assigned investigator sites.
• Assists the CTM with tracking and requesting grant payments, and maintains study budget.
• Tracks and reports all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites and communicates with assigned sites on routine matters.
• Reviews all adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable.
• Reports safety findings in a summary format to the CTM.
• Prepares documentation for and attends Clinical Event Committee (CEC) meetings, if applicable.
• Identifies and documents data errors or items requiring clarification on all documents collected for study and initiates data clarification/validation process after researching source documents.
• Assists in preparing clinical reports of assigned projects for submission to regulatory authorities.
• Performs other duties as required.

Qualifications

• Bachelors Degree in life sciences or BSN.
• 1-2 years experience in relevant Clinical Research. Experience in Phase I-IV clinical studies as a clinical trial assistant or clinical research associate is highly desirable.

Employer Description

• Prepares and completes critical study documents and performs final editing/proofing prior to publishing (e.g. protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; statement of work laboratory, other vendors, and CROs; consultant agreements; investigative device/drug labels; clinical study worksheets; etc.).
• Monitors resources/reports to deliver milestones on time and budget.
• Collect, reviews and files all clinical study documentation for assigned trial(s) and investigative sites and maintenance of clinical trial master file (CTMF): assures all documentation is maintained in compliance with all applicable guidelines and corresponding SOPs.
• Participates, with the CTM, in the preparation and hosting of clinical study team meetings on an established schedule, providing agenda, recording/distributing of minutes and copying of minutes to CTM.
• Works with the CTM to prepare and compile materials for clinical study conduct and reference information for study sites provided to the site in the form of an investigator site file (ISF).
• Prepares, collects and archives all study related correspondence to the investigator site including, but not limited to, newsletters, Dear Dr. letters, FDA/HA correspondence, contractual agreements and others.
• Responsible for investigator recruitment and maintaining current contact information for each assigned investigator site, as well as preparing investigator site file for participation approval.
• Collects pre-study documentation and essential regulatory documents from assigned investigator sites, as well as, collects updated documents prior to study initiation and on an ongoing basis.
• Estimates, orders and coordinates shipments of clinical study supplies to assigned investigator sites.
• Assists the CTM with tracking and requesting grant payments, and maintains study budget.
• Tracks and reports all adverse events, protocol deviations, and any other unusual activity experienced by assigned investigator sites and communicates with assigned sites on routine matters.
• Reviews all adverse events reported in clinical study for the identification and evaluation of safety issues and any patterns that are identifiable.
• Reports safety findings in a summary format to the CTM.
• Prepares documentation for and attends Clinical Event Committee (CEC) meetings, if applicable.
• Identifies and documents data errors or items requiring clarification on all documents collected for study and initiates data clarification/validation process after researching source documents.
• Assists in preparing clinical reports of assigned projects for submission to regulatory authorities.
• Performs other duties as required