Clinical Trial Associate - Hematology

Clinical Waltham, Massachusetts


Description

Position Summary:

The Clinical Trial Associate is a key member of our Clinical team and will play a valuable role in supporting and facilitating the efficient conduct of patient trials in our clinical research programs.

Key Responsibilities Include:

  • Supports the clinical team and the Clinical Trial Manager in the overall management of studies, including planning, execution and closeout of one or more clinical trials
  • Assists the Clinical Trial Manager with site management activities, including review of monitoring reports and tracking of site visits
  • Communicates effectively with internal and external study personnel (investigative staff, vendors, etc)
  • Supports the project team with planning and preparation for investigator meetings and conferences
  • Assists the Clinical Trial Manager with preparation of external and internal documentation for assigned trials and provides study status updates as requested
  • Participates in vendor identification and management (e.g., CROs, IVRS, Central Labs, etc)
  • Assists with the development of vendor and site budgets and supports invoice and budget activities
  • Updates internal and external systems in a timely manner (CTMS, clinicaltrials.gov)
  • Assists with the maintenance of the Trial Master File
  • Participates in clinical operations initiatives and programs as assigned 
  • Identifies, addresses and communicates quality and compliance concerns
  • Other duties as assigned

Education, Registration & Certification:

  • Bachelor’s Degree

Experience:

  • 2-5 years of clinical research experience
  • Prior experience in the Bio-tech industry is preferred

Skills, Knowledge & Abilities:

  • Working knowledge of ICH GCP regulations
  • Strong interpersonal, organizational and multi-tasking skills, attention to detail
  • Therapeutic knowledge preferred 
  • Effective written and verbal communication skills
  • Highly motivated with the ability to be flexible in a fast-paced environment 
  • Proficient computer skills
  • Ability to travel

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

 

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.