Clinical Trial Assistant (Clinical) - Remote - REF10771Z
ProPharma Group3.4
Durham, NC
Job description
Company Description


ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.


Job Description


The Clinical Trial Assistant (CTA) is primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Clinical Trial team. Responsibilities will range from clinical study coordination to data entry projects and general office work.

PRIMARY DUTIES & RESPONSIBILITIES:

  • Work cross-functionally with the study teams internally and externally
  • Collaborate with the study team to develop study-related materials, trackers, and tools
  • Prepare study-related materials for the training of internal and external staff
  • Works within multiple company systems to create, or compile data, for reporting and metric purposes (i.e., eTMF, CTMS, legal web site, etc.)
  • File, track and maintain the Trial Master File (TMF)
  • Coordinate execution of Non-Disclosure and Confidentiality Agreements (NDAs/CDAs) and/or site-specific budgets between the legal team and study sites
  • Review site-specific regulatory packets for completeness and accuracy
  • Assist sites and/or Clinical Research Organization (CRO) with study supplies management
  • Prepare and distribute Investigator Site Files (ISFs)
  • Track site payments and vendor invoices
  • Conduct study closure activities (sites status, reconciliation activities, filing & archiving)
  • Assist with meeting coordination, meeting materials and meeting minutes
  • Track and collate clinical trial documentation related to Clinical Study Report (CSR) appendices, as needed
  • Support quality review of electronic Case Report Forms (eCRFs), eTMF and other study-related activities

Qualifications


Knowledge, skills & abilities:

  • Background in biology, genetics, and/or medical terminology; interest in medical and/or clinical research career
  • Good interpersonal/communication skills
  • Excellent written and verbal communication skills (English).
  • General knowledge of computers and navigating databases
  • Well organized, team-oriented individuals encouraged to apply
  • Proficient in Microsoft Office suite (Word, Excel, PPT)
  • Ability and willingness to travel 25% of the time (post-pandemic).
  • Driven to make a positive impact in cancer diagnosis and treatment.
  • Bachelor’s Degree in biology-related field or equivalent healthcare or laboratory-related work experience
  • At least one year of experience working in clinical research and/or knowledge of Good Clinical Practice (GCP) is preferred

Additional Information


All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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Company details

Headquarters

Overland Park Kansas, United States

Employee

51 to 200

Industry

Consulting and Business Services

Company Description
ProPharma Group is an industry leader providing validation, compliance and technical services to the pharmaceutical, biotechnology, medical device and related industries. Our clients’ business needs and issues are our primary focus. Client speed to market, aggressive deadlines, and a challenging and changing regulatory environment are factors that experienced PPG personnel can assist your organization with in meeting and realizing its competitive advantage. ProPharma Group has developed long-term relationships with clients to whom we provide a wide array of value - added services that complement and support their core business needs. We understand what it takes to deliver a project In-Budget, On-Time, and In-Compliance! ProPharma Group offers the excitement of a consistently evolving career. Our consultants and colleagues are continually learning and working on new and stimulating projects in a variety of regions. The opportunity to travel and work with industry leaders throughout the United States awaits you! We look for people who excel in their technical area of expertise, believe in our values of Experience, Integrity and Commitment and thrive in the collaborative, rigorous and entrepreneurial spirit of the company culture. ProPharma Group develops long-term relationships with clients across the country to which we provide a wide array of value-added services that complement and support their core business needs. We know our employees and consultants are critical to our success in providing the best possible service to our clients.
Company ratings
  • Overall
    3.4
  • Company & Benefits
    3.3 / 5
  • Culture & Values
    3.4 / 5
  • Career Opportunities
    3.0 / 5
  • Work/Life Balance
    3.3 / 5
  • Senior Management
    3.0 / 5
Company reviews
"Supportive "
Former EmployeeAnalyst
Co workers offer good support. Culture is suportive. Salaries are very fair and may include bonuses. There seem to be a lot of mergers and systems are messy.
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Cons:

"Contract work for Novavax"
Current EmployeeSpecialist
Job is fairly easy and straight forward. Managers and colleagues are helpful. There are no live cases yet, but we have been doing live case processing that I will soon feel comfortable when working on my own.
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"Productive and Fun"
Current Employee
Nice company to work for, great staff and help is provided when needed. Managers are responsive in emails. Overall if you are looking for a nice remote job in health science field, this should be great.

"Fair "
Former EmployeeCustomer Service Representative
Good place to work, if you are friendly, cares about employees. Just do your work, know your responsibility. Train if you must. Good benefits.....
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