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Clinical Research Assistant - CAIR and HPNP

Boston Children's Hospital

Boston, MA

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JOB DETAILS
SKILLS
Analysis Skills, Catheterization, Clinical Data Collection, Clinical Data Management, Clinical Research, Clinical Trial, Data Collection, Data Entry, Data Management, Documentation, Drug Development, Gastroenterology, Heparin, Hospital, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Identify Issues, Informed Consent, Medical Writing, Nutrition, Pediatrics, Phase III Clinical Trials, Problem Solving Skills, Psychology, Randomized Controlled Trials, Research Laboratory, Research Skills, Statistical Reports, Statistics, Testing, Total Parenteral Nutrition (TPN)
LOCATION
Boston, MA
POSTED
3 days ago
Position Summary:
The Center for Advanced Intestinal Rehabilitation and Home Parenteral Nutrition Program is seeking a Clinical Research Assistant to support day-to-day study operations, participant engagement, clinical data collection and management, and collaboration with our interdisciplinary gastroenterology and surgical research teams.

The primary study evaluates whether a 4% Tetrasodium (EDTA) catheter lock solution is more effective than standard heparin lock therapy in preventing central venous catheter occlusions and bloodstream infections in children with intestinal failure and short bowel syndrome. The Center for Advanced Intestinal Rehabilitation and Home Parenteral Nutrition Program at BCH is the largest program of its kind and serves as a major site in this 52-week multi-center randomized controlled trial. Participants completing the initial study may also enroll in an extension study, which will additionally fall under this role’s responsibilities.

This position will also support two additional industry-sponsored clinical trials:
  • A multicenter study evaluating DEFENCATH in reducing central-line associated bloodstream infections (CLABSIs) in adults receiving total parenteral nutrition through a central venous catheter.
  • A global Phase 3 trial assessing apraglutide in adults with short bowel syndrome-associated intestinal failure.

Currently, our site has enrolled 27 subjects in the EDTA study, with overall enrollment across participating sites exceeding 75% of the planned recruitment goal. Prior experience with intestinal failure, short bowel syndrome, or parenteral nutrition is not required.

This role offers the opportunity to directly contribute to advancing therapies and improving outcomes for pediatric and adult patients with intestinal failure and short bowel syndrome. This position will also have opportunities to participate in additional clinical research studies and projects as they arise within the program.

Key Responsibilities:
  • Consents and recruits patients for research studies through personal interviews and written communications with patients/families. Provides detailed background information regarding studies to families, communicates all policies and procedures, and responds to all inquiries. Evaluates suitability of prospective study candidates and makes selections based upon clinical knowledge of each study
  • Serves as liaison to the families/patients in the research studies, conducted at both on site and off site locations, guiding and advising them throughout each phase of the study. Coordinates follow up visits as necessary. Acts as a resource to study participants, addressing any concerns they may have. Troubleshoots resolution of any issues that may arise throughout the study
  • Coordinates and prepares the necessary documentation for Institutional Review Board IRB and Committee on Clinical Investigations CCI submissions, together with the Private Investigator of the study
  • Creates and prepares data collection statistical reports and analytical summaries for distribution to study research team for review and analysis. Writes articles and summary papers of studies for submission to medical journals, as may be necessary/requested
  • Participates in the training of newly hired research study assistants, as required
  • Coordinates activities between the hospital and research laboratories to ensure correct testing/processing and send out instructions specific to the study. Communicates project policies and procedures to personnel. Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study

Minimum Qualifications
Education:
• A Bachelor’s Degree in STEM, Psychology or a related field is required

Experience:
  • GI or surgery experience is preferred
  • Ability to make a 2 year commitment is strongly preferred

About the Company

B

Boston Children's Hospital