Sr. Clinical Research Coordinator

Description

Position: Senior Clinical Research Coordinator

Location: Juno Research, Houston, TX

Department: Study Management

Purpose

The purpose of the Senior Clinical Research Coordinator role is to provide advanced coordination, oversight, and leadership in the execution of clinical trials. This position ensures high-quality study conduct by managing key internal and external stakeholder relationships, maintaining regulatory and protocol compliance, and guiding study teams through complex research activities. Senior CRC upholds the highest standards of participant safety, data integrity, and operational efficiency while serving as a trusted resource, mentor, and subject matter expert within the study management team.

Position Summary

The Senior Clinical Research Coordinator position is responsible for managing the key relationships and communication among all internal and external stakeholders involved in a study, keeping all stakeholders informed in a timely and professional manner about the progress and key events with the study. The Senior CRC is expected to accurately identify issues and creatively resolve problems while correcting processes as needed.

The Study Coordinator will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. This position reports to the Site Manager or Site Director.

Key Responsibilities (Essential Functions)

• Maintain required records of study activity including study logs, case report forms, and/or regulatory forms
• Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities.
• Manage multiple concurrent complex trials while anticipating and mitigating potential non-compliance
• Assist with mentoring and training study team members
• Maintain personal training records and ensure study team members training records are up to date on study specific requirements such as protocol amendments, ICFs, updated guidelines, etc.
• Perform all coordinator duties with high degree of quality and professionalism including scheduling and conducting appointments, procedures, assessing eligibility, communicating with the Nursing staff, Laboratory and/or Investigators, educating study volunteers, recording adverse events, ensuring oversight
• Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate pre-study, site qualification, study initiation, monitoring visits, and study close out activities.
• Order and track supplies or devices necessary for study completion.
• Oversee and QC study-related source documentation according to protocol and system guidelines and work with Source Team collaboratively to make appropriate changes.
• Oversee tracking of enrollment status of volunteers and documentation in Clinical Conductor system.
• Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups
  
  

Education And Experience

• BS/BA in Life Science or related discipline or equivalent work experience Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
• Minimum 4 years of experience coordinating clinical trials, including the activities listed above
• Previous nursing, medical assistant experience in a clinical setting a plus
• CCRC certification a plus
• Experience with GCP guidelines and their application
• Training and education experience with coordinating responsibilities and protocol adherence
  
  

Skills And Competencies

• Excellent communication, interpersonal, analytical and problem-solving skills
• Microsoft Office Suite proficiency
• Bilingual Required (location specific): Proficiency in Spanish and English, including the ability to speak, read, and write in both languages
• Writing and verbal communication skills
• Knowledge of medical terminology and concepts
• Proficient typing and data entry skills
• Strong study documentation skills in compliance with ALCOA preferred
• Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc. preferred
• Ability to work effectively with a team
• Ability to manage small projects personally and work independently
• Ability to prioritize and manage multiple projects simultaneously
• Time management skills
• Organizational skills
• Detail oriented with the ability to perform at a high level of accuracy
• Demonstrates strong critical thinking, problem solving skills
• Self-motivated
• Must be results oriented, multi-tasking, quick learner
• Respond to the urgent needs of the team and show a strong track record of meeting deadlines
• Ability to travel for site network support, audits and or attend investigator meetings, as required.
• Demonstrated relationship building, with strong verbal and written skills.
• Ability to successfully coordinate complex protocols with overlapping timelines
• Able to clearly explain and enforce clinical research participant safety requirements including ICF process, role of the IRB and adverse event reporting
• Strong interpersonal skills with attention to detail a must
• Proven ethical and professional codes of conduct
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems.
  
  

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
• Ability to lift and/or move up to 20 pounds
  
  

Why JCCT?

JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States.

We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment.

Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors.

If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!

EEO

JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.