Pinnacle Clinical Research
Clinical Research Coordinator
Pinnacle Clinical Research, Houston, Texas, United States, 77246
Overview
Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Be a part of the discovery!
Summary: PCR seeks a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study participants, as well as document and report on the daily operations of a study and participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information. The Clinical Research Coordinator I must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team-player, and manage multiple projects effectively and efficiently. This role reports directly to the Clinical Research Project Manager.
Duties and Responsibilities
Clinical Trial Execution: Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Project Manager, and Director of Clinical Research Operations
Confidentiality and regulatory compliance: Always maintain subject and document confidentiality, understand, and comply with sponsor requirements and regulations including FDA, good clinical practices, ICH, HIPAA, IRBs, and institutional policies
Study assessments: Complete study-directed assessments with patients including informed consent, subject history, adverse events, Fibroscan, handling of study articles, appointment scheduling, records review, treatment coordination, vital signs, and health assessments
Documentation: Create and complete study-related documents and new study preparation
Liaison: Function as a liaison with pharmaceutical sponsors and external vendors
Study readiness: Prepare for monitor visits (onsite or remote) and audit inspections
Information requests: Respond to internal and external requests for information in a timely manner
Screening and recruitment: Perform subject screening and recruitment
Data management: Contribute to data management for research projects
Quality and patient care: Identify opportunities to improve patient care and satisfaction; conduct patient-facing encounters with compassion, empathy, and thoroughness
Eligibility review: Review medical records against inclusion/exclusion criteria to identify potential subjects
Subject qualification and monitoring: Ensure subject qualifies for study prior to each dose and remains present for post-dose monitoring
Adverse events: Obtain and document adverse event data on appropriate forms
Source data and queries: Ensure source documents are transcribed to the EDC platform per protocol and that EDC queries are answered timely
Communications: Interact with physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients
Project coordination: Coordinate multiple projects with competing priorities and deadlines as dictated by protocol directives
Study-related meetings: Attend investigator meetings, site visits, initiation visits, and other study-related visits hosted by monitors or sponsor representatives as appropriate
Administration
Ensure that electronic case report forms are completed
Create memos, emails, and letters related to study activities
Create and maintain reports and/or spreadsheets as requested
Enter all patient data into the clinical trial management system in a timely manner
Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections
Report safety information to all regulatory agencies
Understand regulatory and IRB requirements for studies
Perform quality checks on source documents specific to the study
Assist with CAPA (Corrective Action Preventive Action) processes as needed
Note: Duties, responsibilities, and activities may change, or new ones may be assigned at any time.
Education / Experience
High school diploma or GED required
Bachelor’s Degree in a scientific area preferred or equivalent combination of education, training, and experience, or internal promotion from Research Assistant role
Proficient in Microsoft Office and Clinical Research IO (CRIO) or equivalent CTMS
Strong knowledge of ICH/GCP guidelines
CITI training required and recertification every 3 years
Fibroscan training and certification (onboarding)
Basic Life Support (BLS) training (onboarding)
Excellent organizational skills and time management with attention to detail and ability to track multiple projects
Strong written and verbal communication skills
Knowledge of basic medical terminology
Integrity and alignment with PCR’s standards and mission
Compliance with company policies and ethics
Proficiency in Spanish and English preferred
Certificates and Licenses
Valid driver’s license and insurance
Knowledge, Skills, and Other Abilities
Effective communication with all levels of internal and external contacts
Ability to work independently and multi-task in a fast-paced team environment
Strong people skills and discretion with confidential information
Positive, friendly, and professional demeanor with patients
Ability to work independently and collaboratively
Ability to interpret clinical research protocols
Strong problem-solving and decision-making under pressure
Proactive issue identification and real-time resolution
Energetic self-starter, results-oriented in an entrepreneurial environment
Work Environment and Physical Demands
Office/laboratory and/or clinical environment
Exposure to biological fluids and/or bloodborne pathogens
Personal protective equipment required
Occasional domestic and/or international travel
Ability to stand or sit for 6-10 hours per day
Frequent mobility; occasional squatting, kneeling, or bending
Light to moderate lifting up to 20-50 lbs
Benefits
401k
Medical, dental, vision, disability, FSA, life insurance
3 weeks of paid time off
14 paid company holidays
Scrub uniform voucher (where applicable)
And more
Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
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Summary: PCR seeks a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study participants, as well as document and report on the daily operations of a study and participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information. The Clinical Research Coordinator I must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team-player, and manage multiple projects effectively and efficiently. This role reports directly to the Clinical Research Project Manager.
Duties and Responsibilities
Clinical Trial Execution: Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Project Manager, and Director of Clinical Research Operations
Confidentiality and regulatory compliance: Always maintain subject and document confidentiality, understand, and comply with sponsor requirements and regulations including FDA, good clinical practices, ICH, HIPAA, IRBs, and institutional policies
Study assessments: Complete study-directed assessments with patients including informed consent, subject history, adverse events, Fibroscan, handling of study articles, appointment scheduling, records review, treatment coordination, vital signs, and health assessments
Documentation: Create and complete study-related documents and new study preparation
Liaison: Function as a liaison with pharmaceutical sponsors and external vendors
Study readiness: Prepare for monitor visits (onsite or remote) and audit inspections
Information requests: Respond to internal and external requests for information in a timely manner
Screening and recruitment: Perform subject screening and recruitment
Data management: Contribute to data management for research projects
Quality and patient care: Identify opportunities to improve patient care and satisfaction; conduct patient-facing encounters with compassion, empathy, and thoroughness
Eligibility review: Review medical records against inclusion/exclusion criteria to identify potential subjects
Subject qualification and monitoring: Ensure subject qualifies for study prior to each dose and remains present for post-dose monitoring
Adverse events: Obtain and document adverse event data on appropriate forms
Source data and queries: Ensure source documents are transcribed to the EDC platform per protocol and that EDC queries are answered timely
Communications: Interact with physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients
Project coordination: Coordinate multiple projects with competing priorities and deadlines as dictated by protocol directives
Study-related meetings: Attend investigator meetings, site visits, initiation visits, and other study-related visits hosted by monitors or sponsor representatives as appropriate
Administration
Ensure that electronic case report forms are completed
Create memos, emails, and letters related to study activities
Create and maintain reports and/or spreadsheets as requested
Enter all patient data into the clinical trial management system in a timely manner
Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections
Report safety information to all regulatory agencies
Understand regulatory and IRB requirements for studies
Perform quality checks on source documents specific to the study
Assist with CAPA (Corrective Action Preventive Action) processes as needed
Note: Duties, responsibilities, and activities may change, or new ones may be assigned at any time.
Education / Experience
High school diploma or GED required
Bachelor’s Degree in a scientific area preferred or equivalent combination of education, training, and experience, or internal promotion from Research Assistant role
Proficient in Microsoft Office and Clinical Research IO (CRIO) or equivalent CTMS
Strong knowledge of ICH/GCP guidelines
CITI training required and recertification every 3 years
Fibroscan training and certification (onboarding)
Basic Life Support (BLS) training (onboarding)
Excellent organizational skills and time management with attention to detail and ability to track multiple projects
Strong written and verbal communication skills
Knowledge of basic medical terminology
Integrity and alignment with PCR’s standards and mission
Compliance with company policies and ethics
Proficiency in Spanish and English preferred
Certificates and Licenses
Valid driver’s license and insurance
Knowledge, Skills, and Other Abilities
Effective communication with all levels of internal and external contacts
Ability to work independently and multi-task in a fast-paced team environment
Strong people skills and discretion with confidential information
Positive, friendly, and professional demeanor with patients
Ability to work independently and collaboratively
Ability to interpret clinical research protocols
Strong problem-solving and decision-making under pressure
Proactive issue identification and real-time resolution
Energetic self-starter, results-oriented in an entrepreneurial environment
Work Environment and Physical Demands
Office/laboratory and/or clinical environment
Exposure to biological fluids and/or bloodborne pathogens
Personal protective equipment required
Occasional domestic and/or international travel
Ability to stand or sit for 6-10 hours per day
Frequent mobility; occasional squatting, kneeling, or bending
Light to moderate lifting up to 20-50 lbs
Benefits
401k
Medical, dental, vision, disability, FSA, life insurance
3 weeks of paid time off
14 paid company holidays
Scrub uniform voucher (where applicable)
And more
Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
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