Central Study CoordinatorCardiology

Work set-up: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Bachelor's degree or equivalent with at least 2 years of related experience., Experience in cardiology studies is required., Proficiency in managing web-based research platforms and clinical databases., Knowledge of ICH/GCP guidelines and applicable regulations..

Key responsibilities:

  • Coordinate and support remote site activities for clinical studies.
  • Serve as the main contact for site communications and document submissions.
  • Assist with patient screening, recruitment, and protocol activities.
  • Maintain documentation compliant with IRB/FDA policies and support study closeout.

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ProPharma Group Large http://www.propharmagroup.com
5001 - 10000 Employees
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Job description

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advisebuildoperate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an endtoend suite of fully customizable consulting solutions that derisk and accelerate our partners’ most highprofile drug and device programs.

  • The Central Study Coordinator position is responsible for the coordination and support of remote site activities for assigned projects. Cardiology experience is required for this role.
  • Essential Function:
  • Serve as point of contact for daytoday Site communications, document submissions and activity coordination.
  • Support prescreening, screening and recruitment activities, as assigned.
  • Responsible for subject reconsenting, acquiring medical records, conducting protocol activities, as directed by the Principal Investigator.
  • Perform dataentry, evaluate and respond to system queries and monitor clinical databases as assigned.
  • Establish and maintain timely Site communication as assigned.
  • Maintain documentation which complies with IRBFDA policies.
  • Assist with study closeout.
  • Assist site with other studyrelated activities as directed.
  • Other duties as assigned.
  • Necessary Skills:
  • Ability to manage technology and webbased research platforms on PC (Microsoft OS) laptop in the remote workspace.
  • Study Tearn experience is ideal.
  • Critical thinking skills.
  • Strong communication Skills (verbal and written).
  • Ability to work independently, and collaboratively with other CSCs to delegate tasks as needed.
  • Working location that has the ability to maintain privacy.
  • Current knowledge of and the ability to apply ICH GCP and applicable regulations and guidelines.
  • Competent in the application of standard business procedures including but not limited to SOPs, global regulations.
  • Well organized and able to multitask.
  • Able to work independently and as a team member.
  • Able to take initiative while following directives.
  • Education Requirements:
  • Bachelors degree or equivalent experience defined as a minimum of 2 years related, combined experience in education, knowledge and skills that will allow one to perform the tasks of the role proficiently.
    • #LImk1 REMOTE

      We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Collaboration
  • Communication
  • Multitasking
  • Critical Thinking
  • Organizational Skills

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