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Clinical Trial Assistant

Company Name:
Corporate Recruiter & Consultant
Clinical Trial Assistant
Will support Clinical Operations to ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. He/she will archive and organize clinical trial master file documents, including clinical study site documents, generate filing indexes and maintain currents lists of correspondence. Responsible for logging in received CRFs and transferring data from the CRFs into the database.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed

Set up CTMS system, as appropriate.
Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations. Help manage clinical, regulatory and study-related essential documents such as study protocols, Informed Consent Forms, etc.
Assist with all aspects of initial study drug release including regulatory packet review and study-drug release.
Assist in the preparation and development of study-specific training materials.
Participate in the planning of investigator meetings.
Assist in the development of case report forms and participate in the EDC and IVRS specification process, as appropriate.
Interact with sites as needed to respond to issues.
Handle incoming and outgoing shipments, as needed. Monitor and track ALL monitoring visit reports. Assist with tracking of clinical trial progress including status update reports, as required.
Participate in the review of clinical data at the case report form, data listing, and report table levels.
Collect enrollment updates and reports on a weekly basis to complete a departmental dashboard.
Assist PM with set up and preparation of weekly client calls.
File and QC trial master files.
Review and maintain up-to-date training records.
Identify and escalate issues appropriately.
May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.

SUPERVISORY RESPONSIBILITIES
Position requires extensive experience and judgment to accomplish study defined goals. May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION and/or EXPERIENCE
BS/BA preferred. School diploma/certificate or educational equivalent; or equivalent combination of education, training and experience. Must possess a general knowledge of applicable clinical research regulatory requirements; including GCP and ICH guidelines. Minimum of 2 of CRC experience required with two years. Strong working knowledge of Clinical Research procedures and guidelines, required. Extensive organizing and coordinating skills. Solid understanding of clinical drug development is preferred

SKILLS and/or ABILITIES
Ability to enter data into PC accurately including experience working with Microsoft Office. Strong written and verbal communication skills. Effective time management and organizational skills. Attention to detail and accuracy in work. Strong customer service orientation. Ability to work effectively and efficiently handling multiple tasks simultaneously. Ability to facilitate a teamwork philosophy with a positive attitude.

LANGUAGE SKILLS
Ability to read, interprets, and understands documents and reports containing pertinent information relating the clinical research protocols. Ability to respond effectively to all inquiries. Ability to write routine reports and complete clinical documentation. Ability to comprehend medical terminology. Ability to effectively communicate with physicians, nurses, other team members, and representatives from outside organizations.

MATHEMATICAL SKILLS
Ability to add, subtracts, multiply, and divides using whole numbers, common fractions, and decimals.

REASONING / PROBLEM SOLVING ABILITY
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, or schedule form. Must have the ability to multi-task and effectively solve problems.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is frequently required to use hands to finger, handle, or feel; stand; and talk or hear. Employee regularly reaches with hands and arms. The employee periodically is required to lift and/or carry up to 10 pounds. Occasionally, employee stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Works in a standard office environment where the noise level is usually quiet to moderate. Employee also works in an environment associated with patient care where the noise levels may vary. Employee is subject to many interruptions; pressure due to deadline requirements; and handling multiple tasks simultaneously while performing assigned duties. Employee may be exposed to infectious, radioactive or biohazardous agents and possibly exposed to the risk of blood borne pathogens.

SAFETY REQUIREMENTS
Employee is required to pay particular attention to safety practices including following all safety, environmental, and infection control guidelines, procedures and protocols including wearing appropriate safety/protective equipment.

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