Sr. Clinical Research Coordinator

Johnson County Clintrials LLC•Houston, TX

20h

About The Position

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. 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.

Requirements

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
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.

Nice To Haves

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

Responsibilities

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