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PURPOSE AND SCOPE:
The main focus of the Project Assistant is to provide support to the members of the clinical project team, in order to facilitate management of clinical trials. The Project Assistant will ensure that the Project Manager is reinforced in the implementation, maintenance, and close-out of research trials. Project Assistant is expected to have working knowledge of databases and programs and perform administrative tasks to back the team members with clinical trial execution as needed.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Effectively utilizes databases and programs as deemed necessary.
Maintains clinical project files to internal standards and regulatory requirements.
Contributes to the preparation of presentations and reports.
Ensures study documents meet FDA/ICH/GCP guidelines.
Collects and prepares information for use in discussions/meetings.
Attends and records minutes for internal and external clinical meetings.
Provides recordkeeping and reporting to support investigator payments for assigned projects.
Prepares, track and review patient payments
Collects enrollment of patients to assure each subject is flagged appropriately in the systems.
Effectively communicates with internal and external personnel, as well as clients and vendors.
Establishes and maintains trial master files (i.e., hard copy and electronic folder set-up, filing, tracking, archiving) in compliance with SOPs, ICH and GCPs.
Creates and maintains study tracking documents.
Collects study documents from investigative sites, reviews and prepares document submissions to review boards for approval
Tracks and assists with study start up activities
Tracks study specific training at site and facility level
Tracks the SVP review and approvals for study conduct at sites and tracks corporate review and approvals for study conduct at facilities.
Maintain sponsor/study-required databases.
Creates and maintains study tracking documents
Liaise with internal data management team to trouble shoot issues on data deliverables
Develops and implements study-related materials and coordinates distribution to sites.
Assists with development of tools that can be utilized across studies.
Provides solutions to routine project questions and issues related to project milestones and deliverables to ensure that projects remain on schedule, while meeting quality expectations and client satisfaction goals.
Under general supervision, follows established company policies and procedures and applies acquired job skills.
Drives issues to closure, despite obstacles and opposition. Maintains positive attitude throughout process.
Performs functions that require full knowledge of general aspects of the job.
May be asked to perform assignments requiring considerable research and initiative.
Provides review of site regulatory documents for compliance with ICH GCPs and FDA guidelines and regulations related to clinical trials.
Provides PM support for project timelines, action item follow-up, monthly reporting requirements and technical Provides administrative support, including document preparation, scheduling, and meeting coordination May be assigned specifically to one or more distinct projects which supports Project Manager and team.
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Assists with various projects as assigned by direct supervisor.
Must maintain confidentiality and a high degree of sensitivity inside and outside of the company.
Other duties as assigned.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Travel 10% or less.
Availability outside of office hours required as needed (through e-mail, phone, etc.)
EDUCATION:
Required: Bachelor's degree in subject matter relevant to the position (if no Bachelors, then 5 years of direct relevant experience in a similar role in the Pharmaceutical/Biotech or Device industry)
Participation in and documentation of training on GCP/ICH Guidelines and FDA regulations for clinical trials in the drug, biotech or device industry.
EXPERIENCE AND REQUIRED SKILLS:
1 - 2 years' related experience (Project Assistant).
Familiarity with study compliance (FDA ,ICH GCP) and local regulations. Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance required.
Advanced computer proficiency, especially MS Office.
Ability to multi-task, work independently, take initiative, and complete tasks to deadline.
Excellent oral and communication skills.
Superior customer service skills.
Excellent time management and organizational skills.
Experience with an electronic Clinical Trial Management System preferred.