The Lead Clinical Research Coordinator (CRC) is responsible for the overall organization and operational administration of protocols assigned. The Lead CRC works in conjunction with an Assistant CRC to ensure quality and cohesive progress is maintained throughout the study. As the primary internal point of contact, the Lead CRC must maintain open communication with departments pertaining to the conduct and execution of clinical studies.
ESSENTIAL JOB FUNCTIONS
- Facilitates and coordinates daily clinical trial activities with minimal supervision and plays a critical role in the conduct of a Project/Trial
- Reads and comprehends each assigned protocol including study proceedings and timelines
- Participate in all essential Project/Trial meeting including but not limited award, planning, dose strategy and SIV.
- Facilitates and leads Project/Trial training which include but is not limited to Screening, dosing, dry run, lab, protocol amendment (if applicable), and equipment (if applicable) to ensure staff are properly trained and delegated by the Principal Investigator.
- Ensures all Project/Trial assigned pre-study activities are completed within set timelines which include but not limited to the creation of essential regulatory documents/site operational forms (floor set-up, supply request meal calendar, study participant check log, etc.), Lab requisition forms/reports, study summaries. In addition perform accurate review of ICF, source documents, and Master Log.
- Determines supplies and equipment needed for the conduct of the Project/Trial and ensures all items are ordered and received and available prior to study start.
- Coordinates Sponsor visits with the site Project Managers which include SIV, IMV, COV, and audit visits. Also responsible for meeting with the MONITOR at the beginning and end of each visit to provide Project/Trial status updates, answer question, review of pending action items and provide timely response to all open queries.
- Ensures timely maintenance and accuracy of the all essential regulatory documents as well as site operational documents and logs.
- Works collaboratively with other members of the Project/Trial team, administrative support teams and Quality Management Services to ensure success through planning, training, and conduct from study start-up to study close-out.
- Ensures adequate qualified and delegated staff are scheduled for all Project/Trial visit/procedure days.
- Consents study participants and/or re-consent study participants with an amended consent in compliance with ICH GCP and Federal regulations.
- Ensures set up of the CPU for the conduct of the Project/Trial.
- Ensures 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.
- Ensures 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.
- Ensures all in-house activities and Project/Trial procedures are performed in compliance with the Project/Trial protocol, Federal Regulations, ICH GCP, GDP, HIPAA and site SOP’s and Work instructions. Oversees and coordinates activities on all Project/Trial visit days.
- Ensures accuracy of the Final Master Log at all times throughout the Project/Trial which includes but not limited to subject information, enrollment status, and dosing times.
- Ensures subject safety by maintaining accurate records of adverse events, concomitant medications, and abnormal laboratory results, and out of range ECG/Vital signs readings for Investigator timely review and assessment.
- Provide timely communication to Sponsor, Project Manager, Regulatory Coordinator, and contracted vendors for study-specific needs, as needed.
- Establishes and accurately organizes study files including but not limited to regulatory binders, study specific source documentation and other materials as required.
- Provide timely communication including, but not limited to: Sponsor, site Project Manager, Regulatory Coordinator, and contracted vendors for study-specific needs, as needed.
- Independently creates administrative and study memorandums.
- Assist QMS in preparing and hosting all external audits including but not limited to Sponsor, IRB, and FDA.
- Collaborates with the PI and Site Director to respond to any audit findings and assists in the implementation of approved corrective action.
- Works as part of a team or independently.
- Assist other Lead Coordinators and research staff as needed for operational coverage.
- Delegate and/or endorse clerical and operational duties to study team members and support staff.
- Educate and mentors Assistant Clinical Research Coordinator and Clinical Research Technician
- May perform other job related duties as requested or required.
The lead CRC ensures completion of all tasks above. They may delegate to supporting staff, but are ultimately responsible for satisfactory completion of study conduct.
QUALIFICATIONS AND 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
- Promotes the ethical conduct of research by reporting good faith suspicions of misconduct of ICH GCP, GDP, Federal Regulations, site SOPs/Work Instructions, and Employee Handbook to the Executive Director, Operations or Designee
- 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
- 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
- Current BLS certification required.
- Bachelor’s degree and 6 months of clinical research experience required, 2 years of clinical research experience preferred; or 1 year of commensurate clinical research experience required, 2-4 years of commensurate clinical research experience preferred for those without bachelor’s degree preferred.
- Licensed Vocation Nurse or Medical Assistant or Phlebotomy Technician (CPT1)
- Clinical research experience minimum 2 years 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.