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Clinical Research Associate

Company Overview
Imagine if we could accelerate healthcare discovery leading to more effective treatment and cures. Here at iSpecimen, we are working to get researchers the specimens they need from the patients they want to do just that. Headquartered in Lexington, MA, iSpecimen is the marketplace for human biospecimen collections. iSpecimen has developed the iSpecimen Marketplace, an online platform connecting healthcare organizations that have access to patients and specimens with the scientists who need them.

Position Overview
iSpecimen is currently looking for a Clinical Research Associate to join our team. This individual will be responsible for coordinating a variety of ongoing research collections. This includes participation in the feasibility assessment process, creation and distribution of Statements of Work, and project management that includes oversight of collections/shipments scheduling. This position will work closely with iSpecimen sales personnel, researchers, and clinical research partners so great communications skills is a must.

This position includes a combination of in-office and remote work.

Responsibilities

  • Working with sales, supply sites, and our technology, respond to customer inquiries to understand requirements for tissue and related biofluid prospective collections.
  • Capture and organize requirements, assign feasibility assessments to supply sites, and track and manage feasibility assessments.
  • Create proper order paperwork and statements of work to initiate orders at supply sites.
  • Assist with the creation, development and management of clinical study documents such as study timeline, case report forms, informed consent forms, enrollment tracking, protocol, study logs and forms, regulatory binders, interim and final reports, status updates and other study documents.
  • Train collections sites using project-specific instructions.
  • Work with team to define, build, distribute and manage kits.
  • Manage existing orders using iSpecimen Marketplace, Salesforce and other technologies.
  • Maintain strong relationships with suppliers.
  • Work with technology team to identify software enhancements needed to more efficiently bring opportunities from inquiry to fulfilment.
  • Communicate relevant supply site issues to iSpecimen Fulfilment, Sales, and Implementation and Technology teams.
  • Coordinate patient collection and specimen shipment schedules between suppliers and customers
  • Support the Sales and Operations teams in resolving customer and supply issues

Required Qualifications

  • Associates or bachelor’s degree preferred
  • Minimum 1 year of experience working in an energetic team environment
  • Minimum 1 year of document writing experience
  • Knowledge of clinical trials, IRB protocols and related topics
  • Knowledge of Good Clinical Practices (GCP) and FDA regulations related to clinical research

Required Attributes

  • Strong document writing skills absolutely essential
  • Exceptional technological and Computer skills, including intermediate mastery of Microsoft Excel, Word, and PowerPoint
  • Great organizational skills are essential. Must have a strong commitment to THOROUGH resolution of issues & completion of tasks, and ability to organize to get there.
  • Great interpersonal skills. Someone who likes working with people, has a positive attitude, and is energetic.
  • Exceptional email communication skills (confidence on the phone is a plus). Must be extremely confident in demonstrating control over a situation and communicating points effectively + professionally.
  • Self-starter who likes to get things done and has an appetite for continuous learning
  • Ability to handle a fast-paced environment, think creatively and come up with new, valuable approaches

Benefits
iSpecimen offers a generous suite of comprehensive benefits including ten paid holidays per year, unlimited paid time off (PTO) for vacation, sick, or personal use, health, dental, and vision insurance, health savings accounts, and a 401(K) retirement plan.

iSpecimen is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, pregnancy, disability, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, gender identity, or any other characteristic protected by applicable federal, state or local laws.

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