Clinical Trials Research Associate - Gastroenterology/Hepatology
4.
1 Full-time 9 hours ago Full Job Description The Clinical Trial & Database Management Research Associate will serve as a member of the research team at the University of Iowa, Division of Gastroenterology and Hepatology within Internal Medicine.
The primary responsibility is to support, conduct and manage clinical trials to deliver and evaluate research protocols and clinical trials in the Division.
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 RESPONSIBILITY Protocol Development/ Management and Study
Responsibilities:
Consult with researchers to assist in development of data management plans; design forms to facilitate the collection and tracking of study participant data, study drugs, biological specimens and study procedures.
Assist in the design, development, execution, administration and maintenance of protocols and clinical studies.
Assist in study design and protocol development and provide input into descriptions of complex research procedures.
Oversee CRF development.
Assist with query reports.
Oversee monitoring visit issues.
Develop complex study materials.
Serve as liaison to local health care practitioners, agencies and sponsors.
Lead study coordinator for observational studies.
Research/Clinical Activities; Subject Recruitment and Enrollment:
Assist with clinical and data coordination for research activities and set up supplies for study visits and schedule trial-related procedures.
Lead for the recruitment of subjects by mining databases and EPIC and recruiting subjects from the providers clinics in the Digestive Health Center.
Perform telephone screening of potential subjects to determine initial eligibility for enrollment.
Data Collection and Monitoring:
Participate in the design; development and testing of clinical research trials data systems.
Validate data, query resolution and make recommendations for resolution.
Revise and implement change in data collection.
Perform all data processing tasks; enter data, verify data, identify problem data, generate queries, etc.
Perform lab draws, EKGs, and fibroscans on research subjects.
Regulatory Guidelines and Documents:
Manage and organize regulatory documentation from sites and regulatory authorities.
Prepare regulatory submissions and start-up activities for new studies Perform on-site audits or research and clinical data.
Monitor compliance of regulatory guidelines and proper maintenance of documents.
May recommend corrective action for reportable events.
Assist with obtaining signatures on regulatory documents and point of contact for monitors.
Human Resources/Leadership:
May provide functional and/or administrative supervision.
Mentor new staff under direction.
Financial Responsibility:
May develop and manage budget for studies.
About Gastroenterology/Hepatology Since its foundation nearly 40 years ago, the Division of Gastroenterology and Hepatology has continuously distinguished itself as a highly ranked specialty within the Department of Internal Medicine.
As part of the James A.
Clifton Digestive Health Center, it provides state of the art medical care to patients with gastrointestinal or liver diseases and nutritional problems in a multidisciplinary environment.
The Center also plays an important role in the education of students, residents and fellows and offers a variety of learning opportunities for continuing medical education of physicians and other health care professionals.
The nationally and internationally recognized faculty conducts many clinical and basic science research projects to further our understanding of gastrointestinal and liver diseases and help design better treatment for patients with these illnesses.
Click here to learn more about our team! Required Qualifications A Bachelor's degree or an equivalent combination of education and experience is required.
6 months - 1 year of related experience including experience with preparation of IRB submissions or regulatory submissions and participation with clinical trials is required.
Excellent written and verbal communication skills are required.
Excellent time management skills and the ability to perform detail oriented work independently is required Proficiency in computer software applications (MS Word, Excel, Outlook and PowerPoint) is required.
Desirable Qualifications Experience with EPIC is desirable.
Experience with following specific protocol techniques and management is desirable.
Knowledge of University of Iowa policies, procedures and regulations is desirable.
Position and Application Details In 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 kiley-skay@uiowa.
edu Benefits Highlights Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans The University of Iowa offers a generous benefits package, including paid vacation and paid sick leave.
Complete information regarding the full benefits package may be viewed at:
https:
//hr.
uiowa.
edu/benefits/fpsm.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
1 Full-time 9 hours ago Full Job Description The Clinical Trial & Database Management Research Associate will serve as a member of the research team at the University of Iowa, Division of Gastroenterology and Hepatology within Internal Medicine.
The primary responsibility is to support, conduct and manage clinical trials to deliver and evaluate research protocols and clinical trials in the Division.
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 RESPONSIBILITY Protocol Development/ Management and Study
Responsibilities:
Consult with researchers to assist in development of data management plans; design forms to facilitate the collection and tracking of study participant data, study drugs, biological specimens and study procedures.
Assist in the design, development, execution, administration and maintenance of protocols and clinical studies.
Assist in study design and protocol development and provide input into descriptions of complex research procedures.
Oversee CRF development.
Assist with query reports.
Oversee monitoring visit issues.
Develop complex study materials.
Serve as liaison to local health care practitioners, agencies and sponsors.
Lead study coordinator for observational studies.
Research/Clinical Activities; Subject Recruitment and Enrollment:
Assist with clinical and data coordination for research activities and set up supplies for study visits and schedule trial-related procedures.
Lead for the recruitment of subjects by mining databases and EPIC and recruiting subjects from the providers clinics in the Digestive Health Center.
Perform telephone screening of potential subjects to determine initial eligibility for enrollment.
Data Collection and Monitoring:
Participate in the design; development and testing of clinical research trials data systems.
Validate data, query resolution and make recommendations for resolution.
Revise and implement change in data collection.
Perform all data processing tasks; enter data, verify data, identify problem data, generate queries, etc.
Perform lab draws, EKGs, and fibroscans on research subjects.
Regulatory Guidelines and Documents:
Manage and organize regulatory documentation from sites and regulatory authorities.
Prepare regulatory submissions and start-up activities for new studies Perform on-site audits or research and clinical data.
Monitor compliance of regulatory guidelines and proper maintenance of documents.
May recommend corrective action for reportable events.
Assist with obtaining signatures on regulatory documents and point of contact for monitors.
Human Resources/Leadership:
May provide functional and/or administrative supervision.
Mentor new staff under direction.
Financial Responsibility:
May develop and manage budget for studies.
About Gastroenterology/Hepatology Since its foundation nearly 40 years ago, the Division of Gastroenterology and Hepatology has continuously distinguished itself as a highly ranked specialty within the Department of Internal Medicine.
As part of the James A.
Clifton Digestive Health Center, it provides state of the art medical care to patients with gastrointestinal or liver diseases and nutritional problems in a multidisciplinary environment.
The Center also plays an important role in the education of students, residents and fellows and offers a variety of learning opportunities for continuing medical education of physicians and other health care professionals.
The nationally and internationally recognized faculty conducts many clinical and basic science research projects to further our understanding of gastrointestinal and liver diseases and help design better treatment for patients with these illnesses.
Click here to learn more about our team! Required Qualifications A Bachelor's degree or an equivalent combination of education and experience is required.
6 months - 1 year of related experience including experience with preparation of IRB submissions or regulatory submissions and participation with clinical trials is required.
Excellent written and verbal communication skills are required.
Excellent time management skills and the ability to perform detail oriented work independently is required Proficiency in computer software applications (MS Word, Excel, Outlook and PowerPoint) is required.
Desirable Qualifications Experience with EPIC is desirable.
Experience with following specific protocol techniques and management is desirable.
Knowledge of University of Iowa policies, procedures and regulations is desirable.
Position and Application Details In 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 kiley-skay@uiowa.
edu Benefits Highlights Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans The University of Iowa offers a generous benefits package, including paid vacation and paid sick leave.
Complete information regarding the full benefits package may be viewed at:
https:
//hr.
uiowa.
edu/benefits/fpsm.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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