Description
Project Administration Specialist Intern
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.Job responsibilities
• Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs), and GCP & ICH Guidelines.
• Assists with maintenance of Trial Master File (TMF), perform TMF document process activities such as preparing documents, submission, re-classifying, deleting duplicate documents, and editing metadata.
• Perform thorough ALCOA quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues or queries identified.
o ALCOA (Attributable, Legible, Contemporaneous, Original & Accurate)
• Maintain timely and effective communication with study team regarding assigned task & deliverables.
• Assist study teams with administrative and clerical task such as:
o Study Filing (i.e. Study Team Curriculum Vitae (CVs), Study Correspondence, Monitoring Reports, Monitoring Letters, & Telephone Contact Reports
o Management of helpdesk tickets requesting and revoking access to systems (i.e. Electronic Data Capture, Clinical Trial Management System (CTMS))
o CTMS Site Information Entry
o Provide Study Specific Training Compliance Reports
o Formatting Study Team Newsletters
o CV conversions to one page (if required)
o Preparation of draft IRB application form & package for IRB submission of safety reports
o Preparation of the required documents for SIV, IMV and COV
o Support payment of investigator fee and IRB review fee
o Support the document translation process, including requesting quotes from translation vendors
• Maintain compliance with departmental quality, performance and utilization targets.
• Support logistics for department and/or external meetings accordingly
• Prepare and produce materials and presentations for Manager/Mentor meetings as requested
• Collaborate with interns/colleagues from other regions of the world and learn from their job scopes
• Assist with data collection and analysis
• Performs other work-related duties as assigned.
Potential Growth Job Responsibilities
• Within the Clinical Training Institutue: Potentially participate in the CRA I Training Program (Clinical Training Institute), a 12-16 week full-time training program credentialed by The International Accrediting Organization for Clinical Research (IAOCR) and results in competent and motivated CRAs who have the training, tools, and resources to provide quality delivery. Tasks consist of:
o Independent work in the form of pre/post-requisites
o Virtual Instructor-Led (vILT) live sessions
o 2-day virtual simulation
• Within the CRA Role, Familiarisation and Support of:
o Gain exposure to and potentially support Primary CRAs with site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
o Gain exposure to learn the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
o Gain experience from Primary Monitors in familiarising with the Clinical Monitoring/Site Management Plan (CMP/SMP) to:
o Learn how assessment of site processes is conducted
o Learn how Source Document Review of appropriate site source documents and medical records is conducted
o Learn how required clinical data entered in the case report form (CRF) is accurate and complete
o Learn how query resolution techniques remotely and on site are applied, and how guidance to site staff as necessary is provided in driving query resolution to closure within agreed timelines
o Learn how available hardware and software to support the effective conduct of the clinical project data review and capture is utilised
o Learn how site compliance with electronic data capture requirements is verified
o Gain exposure to and potentially support Primary CRAs with Investigational Product (IP) Reconciliation activities, Investigator Site File (ISF) and Trial master File (TMF) review for accuracy and completeness
o Gain exposure to and familiarity with how a Primary CRA acts as a liaison with project site personal, and how the primary CRA ensures sites are audit and inspection ready
Qualifications
Qualification
• Degree in the biological sciences or related discipline in the natural sciences/health care preferred
• Administrative Experience.
• Ability to embrace new technologies.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, database applications), email, and internet
• Strong communication and presentation skills, interpersonal skills, as well as a team oriented approach
• Excellent verbal, written, communication and time management skill.
• Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high quality work
• Ability to be flexible, adapt to change, work independently, as well as work as part of a team in a matrix environment.
• Proficiency in the English language both written and verbal.
• Minimal clinical or research experience preferred.
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.
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.