Clinical Research Coordinator
American Clinical Research Services Opco LLC
Behavioral Health Market Context
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Job Description
e, and monitoring participant progress.
Responsibilities
• Performs study subject.
• Screens and recruits’ subjects.
• Doses and administers study drugs and/or implements study methodologies.
• Accounts for study drugs.
• Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators.
• Accounts for study drugs.
• Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators.
• Collects, labels, stores, and ships specimens collected from subjects in connection with a clinical research trial.
• Enters patient and research data in systems designated by the company.
• Maintains patient charts and resolves research queries.
• Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and site requirements.
• Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms.
• Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals.
• Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
• Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies.
• Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups.
• Creates source documents as assigned, such as regarding protocols, memos, patient participation.
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
• Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions.
• Communicates with laboratories or investigators regarding laboratory findings.
• Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research.
• Orders drugs or devices necessary for study completion.
• Documents findings and events in the Company’s research CTMS platform and in other binders and platforms as directed.
• Occasional travel to Company sites, Principal Meetings, and/or Company meetings.
• Performs other duties as assigned.
Requirements
• Minimum high school diploma required.
• Bachelor's degree in Life Sciences, Nursing, or a related field preferred)
• Bilingual English/ Spanish required
• Knowledge of clinical trial management software and electronic data capture systems required
• 2+ Years of previous CRC experience required
• Familiarity with Good Clinical Practice (GCP) and regulatory guidelines (FDA, ICH) required
• Enthusiasm for clinical research and a desire to learn required
• Strong organizational and time management skills.
• Excellent attention to detail and ability to maintain accurate records.
• Effective communication skills, both written and verbal.
• Ability to work independently and collaboratively in a team environment.
• Proactive problem-solving skills and adaptability in a dynamic setting.
Nice-to-haves
• Certification as a Clinical Research Coordinator (e.g., ACRP, SOCRA) is a plus but not required
Responsibilities
• Performs study subject.
• Screens and recruits’ subjects.
• Doses and administers study drugs and/or implements study methodologies.
• Accounts for study drugs.
• Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators.
• Accounts for study drugs.
• Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators.
• Collects, labels, stores, and ships specimens collected from subjects in connection with a clinical research trial.
• Enters patient and research data in systems designated by the company.
• Maintains patient charts and resolves research queries.
• Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and site requirements.
• Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms.
• Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals.
• Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
• Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies.
• Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups.
• Creates source documents as assigned, such as regarding protocols, memos, patient participation.
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
• Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions.
• Communicates with laboratories or investigators regarding laboratory findings.
• Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research.
• Orders drugs or devices necessary for study completion.
• Documents findings and events in the Company’s research CTMS platform and in other binders and platforms as directed.
• Occasional travel to Company sites, Principal Meetings, and/or Company meetings.
• Performs other duties as assigned.
Requirements
• Minimum high school diploma required.
• Bachelor's degree in Life Sciences, Nursing, or a related field preferred)
• Bilingual English/ Spanish required
• Knowledge of clinical trial management software and electronic data capture systems required
• 2+ Years of previous CRC experience required
• Familiarity with Good Clinical Practice (GCP) and regulatory guidelines (FDA, ICH) required
• Enthusiasm for clinical research and a desire to learn required
• Strong organizational and time management skills.
• Excellent attention to detail and ability to maintain accurate records.
• Effective communication skills, both written and verbal.
• Ability to work independently and collaboratively in a team environment.
• Proactive problem-solving skills and adaptability in a dynamic setting.
Nice-to-haves
• Certification as a Clinical Research Coordinator (e.g., ACRP, SOCRA) is a plus but not required
Qualifications
- •Minimum high school diploma required
- •Bilingual English/ Spanish required
- •Knowledge of clinical trial management software and electronic data capture systems required
- •2+ Years of previous CRC experience required
- •Familiarity with Good Clinical Practice (GCP) and regulatory guidelines (FDA, ICH) required
- •Enthusiasm for clinical research and a desire to learn required
- •Strong organizational and time management skills
- •Excellent attention to detail and ability to maintain accurate records
- •Effective communication skills, both written and verbal
- •Ability to work independently and collaboratively in a team environment
- •Proactive problem-solving skills and adaptability in a dynamic setting
Benefits
Responsibilities
- •The Clinical Research Coordinator (CRC) manages and coordinates clinical research studies, ensuring they are conducted efficiently, ethically, and in compliance with regulatory requirements
- •The role involves working with principal investigators, research staff, and study participants to oversee all aspects of trials, including recruitment, data management, regulatory compliance, and monitoring participant progress
- •Performs study subject
- •Screens and recruits’ subjects
- •Doses and administers study drugs and/or implements study methodologies
- •Accounts for study drugs
- •Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators
- •Accounts for study drugs
- •Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators
- •Collects, labels, stores, and ships specimens collected from subjects in connection with a clinical research trial
- •Enters patient and research data in systems designated by the company
- •Maintains patient charts and resolves research queries
- •Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and site requirements
- •Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms
- •Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed
- •Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals
- •Oversees subject enrollment to ensure that informed consent is properly obtained and documented
- •Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies
- •Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups
- •Creates source documents as assigned, such as regarding protocols, memos, patient participation
- •Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports
- •Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks
- •Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures
- •Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions
- •Communicates with laboratories or investigators regarding laboratory findings
- •Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research
- •Orders drugs or devices necessary for study completion
- •Documents findings and events in the Company’s research CTMS platform and in other binders and platforms as directed
- •Occasional travel to Company sites, Principal Meetings, and/or Company meetings
- •Performs other duties as assigned
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