Arch Clinical Trials
This position assists investigators as coordinator of a complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the sponsoring agency, monitoring and the study participants; responsible for managing and recording all phases of study protocol as required by sponsoring agency to ensure compliance.
Duties and Responsibilities: • Coordinates screening and enrollment of clinical trial patients to ensure proper execution of assigned complex clinical research trials and to ensure that study protocols, SOPs, ICH-GCPs and regulatory requirements are met. • Reviews physician-patient schedules and assesses patients for possible clinical trial enrollment. • Educates patients and families during the informed consent process. • Registers patients and participants to protocols. • Ensures eligibility requirements are met and reviewed with the physician investigator. • Ensures protocol-required patient testing is ordered and complete. • Maintains record of recruitment strategies. • Markets protocols as needed to meet recruitment goals. • Coordinates clinical trial activities and research done at the inpatient and outpatient units. • Gathers and verifies source documents • Verifies the accuracy, completeness and timely submission of case report forms. • Collaborates with the investigator to ensure protocol compliance in patient selection, treatment, dose modifications and response. • Interview patients to assess adverse events, medication compliance, and patient-reported outcomes. • Obtains follow-up data required when the patient is off active treatment. • Corrects and resubmits data or answers queries within one week of receipt or as requested by the pharmaceutical company; reviews expectation reports; notifies research base of errors. • Maintains drug inventory • Maintains inventory of individual drug accountability records. • Ensures treatment order is correct by reviewing protocol guidelines and calculating the dose prescribed. • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. • Meets and addresses issues with study monitors, sponsors and regulatory agencies as appropriate. • Respond to queries • Participates in review and development of SOPs, and internal procedures. • Analyzes and develops action plans to address findings, including development of CAPA reports • Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements • Performs CRC, Reviewer and Unit staff duties if required • Maintains adequate, accurate, complete and legible records • Detailed review of subject and study documentation, CRFs and source documents • Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.) • Performs other tasks as assigned and as training and experience allow.
Duties and Responsibilities: • Coordinates screening and enrollment of clinical trial patients to ensure proper execution of assigned complex clinical research trials and to ensure that study protocols, SOPs, ICH-GCPs and regulatory requirements are met. • Reviews physician-patient schedules and assesses patients for possible clinical trial enrollment. • Educates patients and families during the informed consent process. • Registers patients and participants to protocols. • Ensures eligibility requirements are met and reviewed with the physician investigator. • Ensures protocol-required patient testing is ordered and complete. • Maintains record of recruitment strategies. • Markets protocols as needed to meet recruitment goals. • Coordinates clinical trial activities and research done at the inpatient and outpatient units. • Gathers and verifies source documents • Verifies the accuracy, completeness and timely submission of case report forms. • Collaborates with the investigator to ensure protocol compliance in patient selection, treatment, dose modifications and response. • Interview patients to assess adverse events, medication compliance, and patient-reported outcomes. • Obtains follow-up data required when the patient is off active treatment. • Corrects and resubmits data or answers queries within one week of receipt or as requested by the pharmaceutical company; reviews expectation reports; notifies research base of errors. • Maintains drug inventory • Maintains inventory of individual drug accountability records. • Ensures treatment order is correct by reviewing protocol guidelines and calculating the dose prescribed. • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. • Meets and addresses issues with study monitors, sponsors and regulatory agencies as appropriate. • Respond to queries • Participates in review and development of SOPs, and internal procedures. • Analyzes and develops action plans to address findings, including development of CAPA reports • Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements • Performs CRC, Reviewer and Unit staff duties if required • Maintains adequate, accurate, complete and legible records • Detailed review of subject and study documentation, CRFs and source documents • Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.) • Performs other tasks as assigned and as training and experience allow.