Clinical/HC Research Assistant - Cardiology
The Cardiology Division of Internal Medicine at the University of Iowa is seeking a Clinical Trial & Database Management Research Associate.
Responsibilities include overall coordination and administration of clinical trials, regulatory activities, and research protocol development.
Key areas of responsibility include protocol development/management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines, documents and submission; and human resources/leadership.
KEY AREAS OF RESPONSIBILITYProtocol Development/ Management and Study
Responsibilities:
Consults with researchers and assists in development of data management plans; designs forms to facilitate the collection and tracking of study participant data, study drugs, study devices, biological specimens, and study procedures.
Assists in the design, development, execution, administration and maintenance of protocols and clinical studies.
Assists in study design and protocol development.
Provides input into descriptions of complex research procedures.
Develops complex study materials.
Oversees the case report form (CRF) development and form completion.
Assists with query reports.
Oversees monitoring visit issues.
Serves as liaison to local health care practitioners, agencies, and sponsors.
Research/Clinical Activities; Subject Recruitment and Enrollment:
Develops databases for study protocols.
Assists with clinical and data coordination for research activities, obtains informed consent, , sets up supplies for study visits, and schedules trial-related procedures.
Assists with the recruitment of subjects by mining databases and EPIC and recruiting subjects from the providers clinics.
Performs telephone screening of potential subjects to determine initial eligibility for enrollment.
Educates patients on scope of study, potential risks and benefits, possible alternatives, and study requirements.
Data Collection and MonitoringParticipates in the design, development, and testing of clinical research trials data systems.
Maintains study data and records.
Validates data, query resolution, and makes recommendations for resolution.
Revises and implements change in data collection.
Performs all data processing tasks; enters and verifies data, identifies problem data, generates queries, etc.
Conducts audits to assess quality assurance.
Regulatory Guidelines and DocumentsPrepares, manages, and organizes regulatory documentation from sites and regulatory authorities.
Prepares regulatory submissions and start-up activities for new studies and maintains regulatory submissions and documentation for ongoing studies.
Monitors compliance of regulatory guidelines and proper maintenance of documents.
May recommend corrective action for reportable events.
Assists with obtaining signatures on regulatory documents and point of contact for monitors.
Human Resources/Leadership:
May provide functional and/or administrative supervision.
May mentor new staff under the direction of the Clinical Trials Research Manager.
Financial ResponsibilityMay develop, negotiate and manage budget for studies.
Assists with patient compensation.
SUPERVISION RECEIVEDSupervision is received from Clinical Trials Research Manager.
SUPERVISION EXERCISEDFunctional supervision may be exercised over student staff as assigned.
The department intends to hire for one position from either Clinical Research Trials Associate (PRV2), Requisition 22005798 or Clinical/HC Research Assistant (PRA1), Requisition 22005800, based on the qualifications of the successful candidate.
Please apply to the specific position for which you wish to be considered or bothREQUIRED QUALIFICATIONS A Bachelor's degree or an equivalent combination of education and experience is required.
Excellent written, verbal, and interpersonal communication skills.
.
Excellent time management skills with the ability to work independently.
Ability to manage complex information with attention to detail and a high level of accuracy.
Proficiency in computer software applications (MS Word, Excel, Outlook and PowerPoint).
Proven ability to use Medical terminology.
Ability to work flexible hours including evenings and occasional weekends or nights needed by the research protocol.
DESIRED QUALIFICATIONS An Associate's Degree in Nursing, a Diploma in Nursing, a Baccalaureate Degree in Nursing, or a Master's Degree in Nursing is desired.
Current valid Iowa Registered Nurse license.
BLS Certification Previous experience with cardiovascular medicine Phlebotomy experience.
Minimum of 6 months related experience including experience with preparation of Institutional Review Board (IRB) submissions or regulatory submissions and participation with clinical trials.
Previous experience developing, negotiating and managing budgets for studies.
Experience with EPIC.
Knowledge of University of Iowa policies and procedures.
Knowledge of regulatory guidelines and procedures Ability to travel overnight to attend research meetings and/or protocol training.
Application ProcessIn order to be considered for an interview, applicants must upload the following documents and mark them as a Relevant File to the submission:
Resume Cover Letter Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.
Successful candidates will be subject to a criminal background check and education/credential verification.
Up to 5 professional references will be requested at a later step in the recruitment process.
For additional questions, please contact email protected .
Additional Information Classification Title:
Clinical/HC Research Assistant Appointment Type:
Professional and Scientific Schedule:
Full-time Compensation Pay Level:
4A Contact Information Organization:
Healthcare Contact Name:
Michaela Davis Contact Email:
email protected Recommended Skills Administration Attention To Detail Auditing Basic Life Support Biology Case Report Forms Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities include overall coordination and administration of clinical trials, regulatory activities, and research protocol development.
Key areas of responsibility include protocol development/management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines, documents and submission; and human resources/leadership.
KEY AREAS OF RESPONSIBILITYProtocol Development/ Management and Study
Responsibilities:
Consults with researchers and assists in development of data management plans; designs forms to facilitate the collection and tracking of study participant data, study drugs, study devices, biological specimens, and study procedures.
Assists in the design, development, execution, administration and maintenance of protocols and clinical studies.
Assists in study design and protocol development.
Provides input into descriptions of complex research procedures.
Develops complex study materials.
Oversees the case report form (CRF) development and form completion.
Assists with query reports.
Oversees monitoring visit issues.
Serves as liaison to local health care practitioners, agencies, and sponsors.
Research/Clinical Activities; Subject Recruitment and Enrollment:
Develops databases for study protocols.
Assists with clinical and data coordination for research activities, obtains informed consent, , sets up supplies for study visits, and schedules trial-related procedures.
Assists with the recruitment of subjects by mining databases and EPIC and recruiting subjects from the providers clinics.
Performs telephone screening of potential subjects to determine initial eligibility for enrollment.
Educates patients on scope of study, potential risks and benefits, possible alternatives, and study requirements.
Data Collection and MonitoringParticipates in the design, development, and testing of clinical research trials data systems.
Maintains study data and records.
Validates data, query resolution, and makes recommendations for resolution.
Revises and implements change in data collection.
Performs all data processing tasks; enters and verifies data, identifies problem data, generates queries, etc.
Conducts audits to assess quality assurance.
Regulatory Guidelines and DocumentsPrepares, manages, and organizes regulatory documentation from sites and regulatory authorities.
Prepares regulatory submissions and start-up activities for new studies and maintains regulatory submissions and documentation for ongoing studies.
Monitors compliance of regulatory guidelines and proper maintenance of documents.
May recommend corrective action for reportable events.
Assists with obtaining signatures on regulatory documents and point of contact for monitors.
Human Resources/Leadership:
May provide functional and/or administrative supervision.
May mentor new staff under the direction of the Clinical Trials Research Manager.
Financial ResponsibilityMay develop, negotiate and manage budget for studies.
Assists with patient compensation.
SUPERVISION RECEIVEDSupervision is received from Clinical Trials Research Manager.
SUPERVISION EXERCISEDFunctional supervision may be exercised over student staff as assigned.
The department intends to hire for one position from either Clinical Research Trials Associate (PRV2), Requisition 22005798 or Clinical/HC Research Assistant (PRA1), Requisition 22005800, based on the qualifications of the successful candidate.
Please apply to the specific position for which you wish to be considered or bothREQUIRED QUALIFICATIONS A Bachelor's degree or an equivalent combination of education and experience is required.
Excellent written, verbal, and interpersonal communication skills.
.
Excellent time management skills with the ability to work independently.
Ability to manage complex information with attention to detail and a high level of accuracy.
Proficiency in computer software applications (MS Word, Excel, Outlook and PowerPoint).
Proven ability to use Medical terminology.
Ability to work flexible hours including evenings and occasional weekends or nights needed by the research protocol.
DESIRED QUALIFICATIONS An Associate's Degree in Nursing, a Diploma in Nursing, a Baccalaureate Degree in Nursing, or a Master's Degree in Nursing is desired.
Current valid Iowa Registered Nurse license.
BLS Certification Previous experience with cardiovascular medicine Phlebotomy experience.
Minimum of 6 months related experience including experience with preparation of Institutional Review Board (IRB) submissions or regulatory submissions and participation with clinical trials.
Previous experience developing, negotiating and managing budgets for studies.
Experience with EPIC.
Knowledge of University of Iowa policies and procedures.
Knowledge of regulatory guidelines and procedures Ability to travel overnight to attend research meetings and/or protocol training.
Application ProcessIn order to be considered for an interview, applicants must upload the following documents and mark them as a Relevant File to the submission:
Resume Cover Letter Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.
Successful candidates will be subject to a criminal background check and education/credential verification.
Up to 5 professional references will be requested at a later step in the recruitment process.
For additional questions, please contact email protected .
Additional Information Classification Title:
Clinical/HC Research Assistant Appointment Type:
Professional and Scientific Schedule:
Full-time Compensation Pay Level:
4A Contact Information Organization:
Healthcare Contact Name:
Michaela Davis Contact Email:
email protected Recommended Skills Administration Attention To Detail Auditing Basic Life Support Biology Case Report Forms Estimated Salary: $20 to $28 per hour based on qualifications.
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