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Clinical Research Coordinator

Simmaron Research
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Job Description: Research Coordinator for Rapamycin Clinical Trial (NCT04629495)

Position Title: Clinical Research Coordinator
Location: Onsite at the ICBI Monday-Thursday (IU Methodist Hospital)
Employment Type: Full-time/Part-time (specify based on your needs)
Reports To: Principal Investigator

About the Position

Simmaron Research Inc. and its Principal Investigator, C. Gunnar Gottschalk, PhD, are seeking a dedicated and detail-oriented Clinical Research Coordinator to manage and oversee the operational aspects of our decentralized clinical trial evaluating low-dose rapamycin (sirolimus) in patients with ME/CFS, Long-COVID, and other Infection-Associated Chronic Conditions (IACCs). This innovative study is being completed with industry and academic partners and leverages mobile phlebotomy for study sample collection, telemedicine visits, and comprehensive questionnaire and wearable data collection using REDCAP. 

The ideal candidate will assist the PI in the day-to-day trial operations, conducting it in compliance with regulatory guidelines, good clinical practices (GCP), and study protocols while maintaining clear communication with patients, providers, and study partners.

Key Responsibilities

Patient Coordination:

  • Serve as the primary point of contact for study participants, guiding them through the trial process.
  • Schedule and coordinate mobile phlebotomy visits and telemedicine appointments.
  • Process incoming study sample samples (plasma, serum, PBMC, etc.) as they arrive at the Indiana Center for Biomedical Innovation (ICBI) at IU Methodist Hospital. 
  • Monitor patient adherence to study protocols and manage communications regarding the study drug and safety labs.

 

Study Operations:

  • Oversee recruitment efforts and track enrollment milestones.
  • Manage study biospecimens and study data collection, including questionnaires (REDCAP), NIH Common Data Elements, electronic case report forms (eCRFs), and wearable device data.
  • Liaise with AgelessRx to ensure study drug and safety lab orders are delivered to participants.

 

Data Management and Reporting:

  • Maintain accurate and complete records of study-related activities.
  • Assist with biospecimen management, including the creation of study kits. 
  • Monitor data integrity and resolve discrepancies in collaboration with the data management team.
  • Prepare progress reports for the Principal Investigator and sponsor.

 

Regulatory Compliance:

  • Help to ensure the trial meets all regulatory, ethical, and institutional guidelines.
  • Assist with IRB submissions, amendments, and annual reporting requirements.

 

Collaboration and Communication:

  • Coordinate with study sponsors, mobile phlebotomy providers, and collaborators at AgelessRx.
  • Facilitate regular team meetings and disseminate updates to stakeholders.

Qualifications

Education:

  • Bachelor’s degree in a relevant field (e.g., life sciences, public health, or clinical research). Master’s degree preferred.
  • CITI or NIH “Protecting Human Research Subjects” certification 

 

Experience:

  • Experience coordinating clinical trials. Experience with decentralized trials is a plus.
  • Familiarity with REDCAP and GLP laboratory practices for sample processing and storage.
  • Experience with patients.

 

Skills:

  • Strong organizational and time management skills.
  • Excellent written and verbal communication (English).
  • Proficiency in REDCAP and Microsoft Office Suite.
  • Ability to work independently and manage multiple priorities effectively.
  • Compassionate and patient-centered approach to clinical research.

Preferred Qualifications:

  • Data and statistical analysis 
  • Familiarity with biomarker studies and laboratory sample workflows.
  • Wearable devices in the context of clinical research projects.

Compensation and Benefits

  • Competitive salary commensurate with experience.
  • Flexible working hours and remote work opportunities.
  • Professional development and continuing education support.

How to Apply:
Please send your resume and cover letter to C. Gunnar Gottschalk, PhD (Principal Investigator), including "Clinical Research Coordinator - NCT04629495" in the subject line. Applications will be reviewed on a rolling basis until the position is filled.

Email: ggottschalk@simmaron.com

Simmaron Research Inc. is an equal-opportunity employer and values diversity in the workplace.