Description

Job Responsibilities

JOB PURPOSE/SUMMARY:

Assists the team and/or Lead CRA in the conduct of all in-house project activities, and providing administrative support to the clinical project team. Responsibilities typically include preparation, collection, tracking and analysis of data and/or documentation to produce high quality reports. Performs basic in-house & on-site activities.

CORE RESPONSIBILITIES:

• Handles project correspondence
• Composes complex or confidential correspondence
• Creates project specific forms
• Tracks study documentation and clinical supplies
• Tracks site level information
• Creates and maintains central files
• Creates site files and prepares site initiation packets
• Organizes travel arrangements and meetings
• Assists with preparation of meeting minutes
• Organizes presentations, material development and scheduling of project specific training
• Participates in project specific training and project team meetings, as required
• Assists with tracking of site visits and the visit reports
• Assists with adverse event report processing
• Handles receipt and disposition of CRFs from sites
• Assists internal & external customers with general information
• Assists with in-house Investigator/site feasibility activities
• Initiates required administrative systems
• Gathers information, searches files & records, and makes personal contacts to obtain specific information in order to prepare detailed reports for project and company needs
• Other duties and assignments as requested for the overall performance of the OU and company

On-site Activities:

• Reviews site file for completeness/accuracy
• Performs initial review of CRFs for completeness and consistency with source data, including laboratory reports (e.g. all headers complete/consistent, all boxes complete)
• Handles collection & logging of CRF pages
• Conducts Investigational Medicinal Product accountability, prepares material for return/destruction
• Assists with composing visit reports and visit follow-up activities

QUALIFICATIONS:

Education: RN, BS/BA, or equivalent.
Previous practical experience with clinical pharmaceutical research studies in a hospital setting, pharmaceutical company, or CRO preferred. Knowledge of medical and pharmaceutical terminology is desired. Ability to work on a team and independently when required. Candidate/incumbent must be proficient in the use of computer and software systems and have an understanding of basic data processing functions. Excellent decision making, customer service, and interpersonal skills are required. Good command of written and spoken English language.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary