Project Assistant (Remote) Jobs

POSITION FEATURES:

This is a 100% Remote position.

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:

• Collects enrollment of patients to assure each subject is flagged appropriately in the Fresenius systems.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
• Effectively communicates with internal and external Fresenius personnel, as well as clients and vendors.
• Under general supervision, follows established company policies and procedures and applies acquired job skills.
• Attends and records minutes for internal and external clinical meetings.
• Maintain sponsor/study-required databases.
• 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.
• Drives issues to closure, despite obstacles and opposition. Maintains positive attitude throughout process.
• May be asked to perform assignments requiring considerable research and initiative.
• Other duties as assigned.
• Assists with development of tools that can be utilized across studies.
• May be assigned specifically to one or more distinct projects which supports Project Manager and team.
• Performs functions that require full knowledge of general aspects of the job.
• Must maintain confidentiality and a high degree of sensitivity inside and outside of the company.
• Maintains clinical project files to internal standards and regulatory requirements.
• Develops and implements study-related materials and coordinates distribution to sites.
• Ensures study documents meet FDA/ICH/GCP guidelines.
• Tracks study specific training at site and facility level
• Prepares, track and review patient payments
• Effectively utilizes databases and programs as deemed necessary.
• Provides review of site regulatory documents for compliance with ICH GCPs and FDA guidelines and regulations related to clinical trials.
• Provides recordkeeping and reporting to support investigator payments for assigned projects.
• 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
• Contributes to the preparation of presentations and reports.
• Creates and maintains study tracking documents.
• Tracks and assists with study start up activities
• Provides administrative support, including document preparation, scheduling, and meeting coordination
• Provides PM support for project timelines, action item follow-up, monthly reporting requirements and technical
• Assists with various projects as assigned by direct supervisor.
• Collects study documents from investigative sites, reviews and prepares document submissions to review boards for approval
• Liaise with internal data management team to trouble shoot issues on data deliverables
• Tracks the SVP review and approvals for study conduct at sites and tracks Fresenius corporate review and approvals for study conduct at Fresenius facilities.
• Collects and prepares information for use in discussions/meetings.

PHYSICAL DEMANDS AND WORKING CONDITIONS :

• Travel 10% or less.
• 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.
• Availability outside of office hours required as needed (through e-mail, phone, etc.)

EDUCATION :

• Participation in and documentation of training on GCP/ICH Guidelines and FDA regulations for clinical trials in the drug, biotech or device industry.
• 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)

EXPERIENCE AND REQUIRED SKILLS:

• Experience with an electronic Clinical Trial Management System preferred.
• Familiarity with study compliance (FDA ,ICH GCP) and local regulations. Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance required.
• Ability to multi-task, work independently, take initiative, and complete tasks to deadline.
• 1 - 2 years' related experience (Project Assistant).
• Excellent time management and organizational skills.
• Advanced computer proficiency, especially MS Office.
• Superior customer service skills.
• Excellent oral and communication skills.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.