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Assistant Clinical Research Coordinator

JOB SUMMARY

The role of the Assistant Clinical Research Coordinator (ACRC) or Back-Up CRC is to serve as a secondary point of contact and overseer for studies conducted by the Lead CRC. The Assistant CRC is integral member of the core study team managing and coordinating the execution of clinical trials.

ESSENTIAL JOB FUNCTIONS

Essential Duties

  1. Assists the Senior/Lead CRC to facilitates daily clinical trial activities with minimal supervision
  2. Reads and comprehends each assigned protocol including study proceedings and timelines
  3. Assists the Senior/Lead CRC with Project/Trial obligations during start up, conduct, and post study obligations such as but not limited to dry run, Quality Control review draft study documents requiring Senior/Lead CRC final approval (Reminder Card, Source, Master Log), maintenance and filing of essential documents in the site regulatory binder, .maintenance and update of daily used logs (Master Log, Enrollment Log, Protocol Deviation Log), and Quality Control Review of completed source documents and logs (open, verify, close queries).
  4. Participates in all essential Project/Trial meeting including but not limited award, planning, and SIV (training and delegation).
  5. Completes assigned pre-study activities within set timelines.
  6. Assists Senior/Lead CRC complete a thorough quality control review of site and sponsor generated draft source and ensures all documents are in compliance with each assigned Project/Trial protocol and other sponsor provided documents such as but not limited to the Lab/Pharmacy Manual, and CRF.  Submits to Senior/Lead CRC for final approval.
  7. Open new Project/Trial accounts with local lab for each Project/Trial as applicable and order applicable supplies required as per Project/Trial.
  8. Create and maintains logs including but not limited to Project/Trial Training Logs, Delegation of Authority Logs, Enrollment Log, Subject Identification Log, Subject Check Log, Abnormal Lab Log, floor set-up, supply request, study instructions, meal menu, and meal calendar.
  9. Accurately completes Subject Check Request Log and submits to accounting prior to the set Project/Trial payment dates.
  10. Orders supplies and equipment needed for the conduct of the Project/Trial and ensures all items are received and available prior to study start.
  11. Coordinate with Charge Nurse and Nutritionist, if needed, to order study-specific meals from local caterers.
  12. Review of local laboratory requisition form and lab reports for accuracy and submits to Senior/Lead CRC for final approval.
  13. Ensures Project/Trail Safety Laboratory Reports are printed in a timely manner and submitted to an Investigator immediately in the appropriate lab assessment folder with the lab log for assessment.  Reviews investigator requests for repeats and contacts the study volunteer in a timely manner for immediate repeat. 
  14. Attend Project/Trial trainings as applicable which include but not limited to SIV, Dose, Screening, Lab, and study specific equipment training and ensure training and delegation of all staff.
  15. Coordinate with Scheduling Department to ensure adequate qualified and delegated staff are scheduled for all Project/Trial visit/procedure days.
  16. Create Source binders and ensure all study related documents are filed in a timely manner.
  17. Consents study participants and/or re-consent study participants with an amended consent in compliance with ICH GCP and Federal regulations.
  18. Complete Project/Trial Floor Set-Up and supply request and submit to Charge Nurse prior to all scheduled visits.
  19. Coordinate with Facilities Department and complete necessary forms to request subject transportation.
  20. Performs Quality Control review of Project/Trial blood collection tubes to ensure tube type and volume is correct and that the tubes are properly labeled and racked prior to day of blood collection.
  21. Perform all assigned study procedures including but not limited to Vitals, ECG, and Phlebotomy in compliance with the Project/Trial protocol as trained and delegated by the Principal Investigator and in compliance with site SOPs/Work Instructions, Federal Regulations, ICH GCP, and GDP.
  22. Assist Senior/Lead CRC perform internal Quality Assurance review of completed source, issues internal queries, ensures correction of queries from the responsible staff, confirms query response is acceptable, and closes query to ensure timely entry of source data to CRF.
  23. Responds to site or sponsor data clarifications in a timely manner.
  24. Assist Senior/Lead CRC accurately record adverse events, concomitant medications, abnormal laboratory results, and out of range ECG/Vital signs readings for Investigator timely review and assessment.
  25. Assist Senior/Lead CRC accurately organize study files including but not limited to regulatory binders, study specific source documentation and other materials as required, maintain the Protocol Deviation Log and submit to the Senior/Lead CRC for review.
  26. Provide timely communication including, but not limited to: Sponsor, site Project Manager, Regulatory Coordinator, and contracted vendors for study-specific needs, as needed.
  27. Assist QMS in prepare for external audits including but not limited to Sponsor, IRB, FDA.
  28. Serves as the main point of contact in the absence of the Senior/Lead CRC.
  29. Ensures the inventory and secure storage of study documents that will be maintained according to site policy and/or for the contracted length of time, whichever is longer.
  30. Works as part of a team or independently.

Other Duties

  • May perform other job related duties as requested or required by supervisor

QUALIFICATIONS AND REQUIREMENTS

Leadership Requirements

  • Exhibits sound and accurate judgment and logical reasoning
  • Promote a positive, team-orientated, interaction between departments
  • Positive role model; exhibits confidence in self and others

Technical Requirements

  • Knowledge of the Microsoft Office Suite - A proficient user of Microsoft Office Applications including PowerPoint, Word, Excel, Outlook, Project
  • Knowledge of other computer programs – SharePoint, TrialOne

Behavioral Requirements

  • Customer focus - Understanding the needs of the internal or external customer and keeping them in mind when taking actions or making decisions.
  • Team player - Effective participant as a team member and team leader. Can demonstrate significant positive participation on successful teams.
  • Professionalism and integrity - Able to adapt to a changing environment and demonstrates a “make it happen” attitude. Exhibits professionalism in negotiating sensitive issues. Exhibits professionalism in negotiating sensitive issues.
  • Problem solving techniques - Able to adapt to a changing environment and demonstrates a “make it happen” attitude.
  • Interpersonal interaction - Demonstrates excellent people skills and a positive attitude.
  • Communication - Effective verbal communication and presentation skills. Ability to write clear, succinct and convincing memos, letters and articles using original or innovative techniques or style. 
  • Ability to prioritize and to manage multiple tasks as necessary.
  • Attention to detail - Produces high-quality, accurate work with minimal
  • Flexibility - Ability to adapt and be willing to assist with achieving Company goals in the area of responsibility and time.

EDUCATION, CERTIFICATES, LICENSES AND TRAINING

Education

1. Minimum of High School degree required

2. Current Medical Assistant Certification preferred

3. Phlebotomy Technician License (CPT1) preferred

4. Bachelor’s degree or higher in a field related to health science preferred

5. BLS certification required

Experience/Training

  • Clinical research experience minimum 1 year required
  • Requires a thorough knowledge of the: Drug development process, Clinical trial management, Clinical monitoring, FDA regulations, ICH Good Clinical Practice, and Good Documentation Practice, HIPAA

PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT

The description of the physical demands and the work environment characteristics here represent those that must be met by an employee to successfully perform and those an employee encounters while performing the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this job:
  • Ability to talk or hear.
  • Required to sit 90% of the workday.
  • Occasionally required to stand; walk.
  • Must be able to use hands to finger, handle, or feel; reach with hands and arms.
  • Minimal lifting is required, 10 pounds, with assistance and/or move up to 50 pounds.
  • Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus when viewing a computer monitor.
  • While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals and risk of electrical shock.
  • The noise level in the work environment is usually low.

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position.  Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities.  To perform this job successfully, the incumbents will possess the skills aptitudes and abilities to perform each duty proficiently.  Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others.  The requirements listed in this document are the minimum levels of knowledge, skills or abilities.

This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

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