Study Coordinator - Remote (Tamil & English)

Reposted 11 Hours Ago
Be an Early Applicant
Hiring Remotely in India
Remote
Junior
Healthtech • Consulting • Pharmaceutical
The Role
Coordinate day-to-day site communications and document submissions for clinical studies. Support screening, recruitment, re-consenting, medical record collection, protocol activities, data entry, query resolution, maintain IRB/FDA-compliant documentation, assist with closeout, and perform other study-related tasks as directed.
Summary Generated by Built In

For the past 25 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 advise-build-operate 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 end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Employment Type: Part-time (10 hours per week)

Contract Duration: 1-year fixed-term contract with extension to 3 years

Experience: Minimum 2 years of experience as a Study Coordinator

Language Requirements: Fluent in both Tamil and English

Essential Functions:

  • Serve as point of contact for day-to-day Site communications, document submissions and activity coordination.
  • Support pre-screening, screening and recruitment activities, as assigned.
  • Responsible for subject re-consenting, acquiring medical records, conducting protocol activities, as directed by the Principal Investigator.
  • Perform data-entry, 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 IRB/FDA policies.
  • Assist with study closeout.
  • Assist site with other study-related activities as directed.
  • Other duties as assigned.

Necessary Skills and Abilities:

  • Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop in the remote workspace.
  • Study Team 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. · Professional, well spoken, articulate.

Educational Requirements:

  • Bachelor’s 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.

Experience Requirements:

  • Minimum 2 years of study coordinator experience 

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.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

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

Skills Required

  • Fluent in Tamil and English
  • Minimum 2 years of study coordinator experience
  • Bachelor's degree or equivalent experience (minimum 2 years related experience)
  • Current knowledge of and ability to apply ICH/GCP and applicable regulations and guidelines
  • Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop
  • Experience with data entry, responding to system queries, and monitoring clinical databases
  • Competent in application of SOPs and standard business procedures
  • Working location that can maintain privacy
  • Strong verbal and written communication skills; critical thinking; ability to work independently and collaboratively
  • Study team experience
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The Company
HQ: Raleigh, NC
2,059 Employees
Year Founded: 2001

What We Do

ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies. With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science

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