Job Description

JOB TITLE

Clinical Trials Assistant

DEPARTMENT

Clinical Affairs

Non-Exempt

MAIN PURPOSE OF JOB AND OBJECTIVES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Clinical Research Assistant is responsible for providing administrative, organizational, technical, and project management support to Study Manager, for new and ongoing medical device trials.

POSITION IN ORGANISATION

Position in organization can be found on the Organizational Chart via the company intranet.

KEY DUTIES

• Maintain study information on a variety of databases, tracking this information and filing as appropriate.
• Assist Clinical Operations Manager in creating, processing, distributing, and managing the receipt of study-related documents (Protocol, Patient Binders, Newsletters, Regulatory Binders, and initial and updated study documents, etc.)
• Coordinating and scheduling team meetings and teleconferences, with internal and external participants, and responsible for generation of meeting minutes
• Assist Clinical team with managing team calendars, travel arrangements, and expense reports.
• Assist in setting up and maintaining project files (both computer and hard copies)
• Serve as a liaison between Clinical Operations Manager, study centers, regional monitors, and Clinical Research Organization
• Communicate with Clinical Operations Manager as required for study implementation and problem resolution.
• Assist Clinical Operations Manager in tracking site monitoring frequency and monitoring report submission.
• Assist in tracking Pre-Study, Initiation, Interim and Close-Out Monitoring Visits
• Assist in the tracking, communication, and processing of all device orders.
• Assist in coordination of technical support for implants, and responsible for maintaining calendars and implant schedules.
• Assist in reviewing data and outstanding/resolved queries to determine site payments and informing accounting when payments are to be issued.
• Assist in the ongoing review of all Adverse and Serious Adverse Events
• Assist in the processing and tracking of all Clinical Trial Agreements
• Assist in site identification and selection.
• Assist in setting up new study center (sending out study start-up material, providing the site with assistance, coordinating IRB submission, etc.)
• Preparation of correspondence to the sites (mailings, memos/notes to file, etc.)
• Assist in the planning, coordination, set-up, and implementation of Investigator Meetings
• Perform various clerical duties (filing, mailing, faxing, creating site files, etc.)

COMPANY

REQUIREMENTS

1. Must work within requirements of company handbook and policy statements.

Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system

QUALITY

REQUIREMENTS

1. Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
2. Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
3. Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S REQUIREMENTS

1. Take care of your own health and safety and that of others who may
2. be affected by your actions.
3. Work co-operatively to highlight issues affecting Environmental Health and Safety

QUALIFICATIONS & EXPERIENCE

• Excellent written and verbal communication
• Ability to interact with all levels within internal and external organizations.
• B.S. in health care/life sciences (strongly preferred)
• Two years’ experience in commercial, scientific, laboratory, or administration environment
• Extremely detail-oriented and organized, with excellent communication and administrative skills
• Able to manage multiple tasks simultaneously.
• Excellent computer skills, including expertise in Microsoft Office Programs; familiarity with IBM / Lotus Notes beneficial.
• Good understanding of the clinical trial process and regulatory requirements (preferred)

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