Clinical Research Coordinator - AZ - College of Dental Medicine Arizona - Midwestern University
Glendale, AZ
About the Job
Description
Summary
This Clinical Research Coordinator (CRC) is a full-time grant-funded staff position in Midwestern University College of Dental Medicine (CDMA) in Glendale, Arizona. The grant Clinical Research Coordinator will report to the Associate Dean for Research in CDMA and serve as part of the grant research team. The primary responsibilities of this position are to manage dental clinical research processes related to the grant, oversee CDMA faculty and staff on clinical practice-based research systems and electronic data capture systems, serve as the liaison between the dental clinic student and faculty and the research team, and implement quality control procedures for the grant-related research studies within the Dental Institute. Applicants must be comfortable interacting with patients and working in and around an oral environment. Although the CRC is housed in the Dental Institute, this individual will be expected to work with faculty and students both preclinically and clinically. This is a grant funded position with an expected term of 4 years. Occasional travel to local and national conferences to help present novel clinical research outcomes will be required.
Essential Duties and Responsibilities
• Execution of clinical research tasks, to include (but not be limited to): anticipate clinical needs for multiple researcher teams and perform chart review to identify scheduled subjects and complete all forms and requisitions. Working with PIs, this individual will screen, identify and enroll human volunteer participants into clinical practice-based research studies by taking medical histories, administering informed consent forms (ICFs), and obtaining all required signatures. Coordinate daily interactions with patients/subjects, clinicians, and lab personnel and manage study-related scheduling. Communicate with subjects to obtain detailed information on Adverse Events (AEs) and expediently notify study PIs and other key personnel. Follow-up on subject complaints/questions. Manage collection and storage of biological specimens from research studies. Work with Data Management staff to develop source documents and case report forms (CREs) for all clinical research subjects. Order and maintain research supplies and materials.
• Provide daily support for ongoing clinical protocols and assist with completion of clinical measurements and procedures which may include (but not be limited to): verifying patient medical history, obtaining vital signs (height, weight, temperature, pulse, blood pressure), deploying surveys, taking intraoral and facial photographs, and preparing laboratory samples for transport, storage, and/or analysis. Additional clinical responsibilities may include (but not be limited to) making impressions and/or intraoral scans, taking radiographs or working with radiology technicians to take CBCTs, working with research faculty to collect data, and other assessments based on licensure, certifications, and training under the supervision of the Principal Investigator and/or a clinical faculty member.
• Work with clinical monitors/clinical research personnel to facilitate communications for active protocols. Perform timely and accurate recording of patient/subject data into the dental records and research records. Process and gather data concerning NIH data queries and submit to appropriate agency for resolution. Randomize subjects and record visit information. Obtain and disseminate feedback from subjects and investigators.
• Ensure adherence to all documentation requirements and processes. Validate and train CDMA faculty and students on research data collection methods and systems. Train study personnel on CDMA research processes. Attend and deliver protocol presentations at study Investigator meetings and annual dental training/CE events. Assist CDMA faculty with study and/or site audits by government regulatory agencies.
• Assure compliance with policies and protocols of Midwestern University, Institutional Review Boards, FDA/governmental regulations, and multiple research organizations. Assist with drafting and submission of written application forms to the CDMA Research Committee or Midwestern University Institutional Review Board (IRB) for investigator-initiated studies. Contact representatives of such boards and organizations as necessary. Assure patient/subject research confidentiality issues according to Health Insurance Portability and Accountability Act of 1996 (HIPAA). Update clinical research databases.
• Assist in writing grant proposals and in writing research outcomes for publication in peer reviewed dental and medical journals in coordination with the PIs and/or Associate Dean for Research. Assist and participate in case study reviews, abstract submissions, article reviews, and manuscript preparation with faculty and/or students. Help maintain college research website and social media presence.
• Other duties as assigned by the PIs or Associate Dean for Research-CDMA
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. This individual must be able to work in a constant state of alertness and safe manner with regular, predictable, in-person attendance. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This person should enjoy working with college faculty and students as well as the public. The individual should be able to handle complex scheduling issues. Collegiality and teamwork are essential attributes necessary to support a positive work environment.
Education and/or Experience
Bachelor's degree from a four-year College or university is required. This individual must have 3-5 years of work experience related to clinical research. Dental Assisting or Dental Hygiene experience will make the candidate more competitive. Previous experience working in a dental office or hospital setting in a clinical capacity is desired. Clinical research certification (i.e. SOCRA, NIH OCR) desired. Experience working in a team and customer service-oriented environment. Excellent written and verbal communication skills.
Computer Skills
Computer proficiency in MS Office Suite (Word, Excel, Access, Outlook) is required. Proficiency with PowerPoint, EPIC, Canvas, cloud-based project management systems, and the ability to update a webpage is highly desirable.
Mathematical Ability
Intermediate Skills: Ability to add, subtract, multiply, and divide all units of measure using whole numbers, common fractions, and decimals. The ability to compute rate, ratio, and percent and to develop and interpret data in tables and graphs is required. Knowledge of statistical analysis of clinical research data is highly desirable. Ability to manage budgets and compare agency and vendor pricing for obtaining contract services and purchasing, respectively.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will require direct interaction with the human oral environment, recording through digital and analog impressions of the dentoalveolar complex, pouring of impressions and trimming dental models, recording of intra-oral photography, etc.
While performing the duties of this Job, the employee is occasionally required to stand, walk, use hands to handle or feel and reach with hands and arms. The employee is regularly required to sit, talk, and listen/hear. The employee must occasionally lift and /or move up to 20 pounds.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Understanding and compliance with Universal Precautions and wearing the proper personal protective equipment (PPE) along with proper aseptic technique. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position is occasionally exposed to fumes or airborne particles and occasionally exposed to outdoor weather conditions. The noise level in the work environment is usually moderate.
Midwestern University is a private, not-for-profit organization that provides graduate and post-graduate education in the health sciences. The University has two campuses, one in Downers Grove, Illinois and the other in Glendale, Arizona. More than 6,000 full-time students are enrolled in graduate programs in osteopathic medicine, dentistry, pharmacy, physician assistant studies, physical therapy, occupational therapy, nurse anesthesia, cardiovascular perfusion, podiatry, optometry, clinical psychology, speech language pathology, biomedical sciences and veterinary medicine. Over 500 full-time faculty members and 400 staff members are dedicated to the education and development of our students in an environment that encourages learning, respect for all members of the health care team, service, interdisciplinary scholarly activity, and personal growth.
We offer a comprehensive benefits package that includes medical, dental, and vision insurance plans as well as life insurance, short/long term disability and pet insurance. We offer flexible spending accounts including healthcare reimbursement and child/dependent care account. We offer a work life balance with competitive time off package including paid holiday’s, sick/flex days, personal days and vacation days. We offer a 403(b) retirement plan, tuition reimbursement, child care subsidy reimbursement program, identity theft protection and an employee assistance program. Wellness is important to us and we offer a wellness facility on-site with a fully equipped fitness facility.
Midwestern University is an Equal Opportunity/Affirmative Action employer that does not discriminate against an employee or applicant based upon race; color; religion; creed; national origin or ancestry; ethnicity; sex (including pregnancy); gender (including gender expressions, gender identity; and sexual orientation); marital status; age; disability; citizenship; past, current, or prospective service in the uniformed services; genetic information; or any other protected class, in accord with all federal, state and local laws, including 41 C.F.R. 60-1.4(a), 250.5(a), 300.5(a) and 741.5(a). Midwestern University complies with the Smoke-Free Arizona Act (A.R.S. 36-601.01) and the Smoke Free Illinois Act (410 ILCS 82/). Midwestern University complies with the Illinois Equal Pay Act of 2003 and Arizona Equal Pay Acts.
Qualifications
Skills
Preferred
+ Verbal Communication: Advanced
+ Written Communication: Advanced
+ Team/Customer Focused: Intermediate
+ Customer Service: Intermediate
Education
Required
+ Bachelors or better
Experience
Required
+ 3-5 years of experience related to clinical research.
Preferred
+ Experience working in a team and customer service oriented environment.
+ Previous experience working in a dental office or hospital setting in a clinical capacity
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Summary
This Clinical Research Coordinator (CRC) is a full-time grant-funded staff position in Midwestern University College of Dental Medicine (CDMA) in Glendale, Arizona. The grant Clinical Research Coordinator will report to the Associate Dean for Research in CDMA and serve as part of the grant research team. The primary responsibilities of this position are to manage dental clinical research processes related to the grant, oversee CDMA faculty and staff on clinical practice-based research systems and electronic data capture systems, serve as the liaison between the dental clinic student and faculty and the research team, and implement quality control procedures for the grant-related research studies within the Dental Institute. Applicants must be comfortable interacting with patients and working in and around an oral environment. Although the CRC is housed in the Dental Institute, this individual will be expected to work with faculty and students both preclinically and clinically. This is a grant funded position with an expected term of 4 years. Occasional travel to local and national conferences to help present novel clinical research outcomes will be required.
Essential Duties and Responsibilities
• Execution of clinical research tasks, to include (but not be limited to): anticipate clinical needs for multiple researcher teams and perform chart review to identify scheduled subjects and complete all forms and requisitions. Working with PIs, this individual will screen, identify and enroll human volunteer participants into clinical practice-based research studies by taking medical histories, administering informed consent forms (ICFs), and obtaining all required signatures. Coordinate daily interactions with patients/subjects, clinicians, and lab personnel and manage study-related scheduling. Communicate with subjects to obtain detailed information on Adverse Events (AEs) and expediently notify study PIs and other key personnel. Follow-up on subject complaints/questions. Manage collection and storage of biological specimens from research studies. Work with Data Management staff to develop source documents and case report forms (CREs) for all clinical research subjects. Order and maintain research supplies and materials.
• Provide daily support for ongoing clinical protocols and assist with completion of clinical measurements and procedures which may include (but not be limited to): verifying patient medical history, obtaining vital signs (height, weight, temperature, pulse, blood pressure), deploying surveys, taking intraoral and facial photographs, and preparing laboratory samples for transport, storage, and/or analysis. Additional clinical responsibilities may include (but not be limited to) making impressions and/or intraoral scans, taking radiographs or working with radiology technicians to take CBCTs, working with research faculty to collect data, and other assessments based on licensure, certifications, and training under the supervision of the Principal Investigator and/or a clinical faculty member.
• Work with clinical monitors/clinical research personnel to facilitate communications for active protocols. Perform timely and accurate recording of patient/subject data into the dental records and research records. Process and gather data concerning NIH data queries and submit to appropriate agency for resolution. Randomize subjects and record visit information. Obtain and disseminate feedback from subjects and investigators.
• Ensure adherence to all documentation requirements and processes. Validate and train CDMA faculty and students on research data collection methods and systems. Train study personnel on CDMA research processes. Attend and deliver protocol presentations at study Investigator meetings and annual dental training/CE events. Assist CDMA faculty with study and/or site audits by government regulatory agencies.
• Assure compliance with policies and protocols of Midwestern University, Institutional Review Boards, FDA/governmental regulations, and multiple research organizations. Assist with drafting and submission of written application forms to the CDMA Research Committee or Midwestern University Institutional Review Board (IRB) for investigator-initiated studies. Contact representatives of such boards and organizations as necessary. Assure patient/subject research confidentiality issues according to Health Insurance Portability and Accountability Act of 1996 (HIPAA). Update clinical research databases.
• Assist in writing grant proposals and in writing research outcomes for publication in peer reviewed dental and medical journals in coordination with the PIs and/or Associate Dean for Research. Assist and participate in case study reviews, abstract submissions, article reviews, and manuscript preparation with faculty and/or students. Help maintain college research website and social media presence.
• Other duties as assigned by the PIs or Associate Dean for Research-CDMA
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. This individual must be able to work in a constant state of alertness and safe manner with regular, predictable, in-person attendance. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This person should enjoy working with college faculty and students as well as the public. The individual should be able to handle complex scheduling issues. Collegiality and teamwork are essential attributes necessary to support a positive work environment.
Education and/or Experience
Bachelor's degree from a four-year College or university is required. This individual must have 3-5 years of work experience related to clinical research. Dental Assisting or Dental Hygiene experience will make the candidate more competitive. Previous experience working in a dental office or hospital setting in a clinical capacity is desired. Clinical research certification (i.e. SOCRA, NIH OCR) desired. Experience working in a team and customer service-oriented environment. Excellent written and verbal communication skills.
Computer Skills
Computer proficiency in MS Office Suite (Word, Excel, Access, Outlook) is required. Proficiency with PowerPoint, EPIC, Canvas, cloud-based project management systems, and the ability to update a webpage is highly desirable.
Mathematical Ability
Intermediate Skills: Ability to add, subtract, multiply, and divide all units of measure using whole numbers, common fractions, and decimals. The ability to compute rate, ratio, and percent and to develop and interpret data in tables and graphs is required. Knowledge of statistical analysis of clinical research data is highly desirable. Ability to manage budgets and compare agency and vendor pricing for obtaining contract services and purchasing, respectively.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will require direct interaction with the human oral environment, recording through digital and analog impressions of the dentoalveolar complex, pouring of impressions and trimming dental models, recording of intra-oral photography, etc.
While performing the duties of this Job, the employee is occasionally required to stand, walk, use hands to handle or feel and reach with hands and arms. The employee is regularly required to sit, talk, and listen/hear. The employee must occasionally lift and /or move up to 20 pounds.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Understanding and compliance with Universal Precautions and wearing the proper personal protective equipment (PPE) along with proper aseptic technique. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position is occasionally exposed to fumes or airborne particles and occasionally exposed to outdoor weather conditions. The noise level in the work environment is usually moderate.
Midwestern University is a private, not-for-profit organization that provides graduate and post-graduate education in the health sciences. The University has two campuses, one in Downers Grove, Illinois and the other in Glendale, Arizona. More than 6,000 full-time students are enrolled in graduate programs in osteopathic medicine, dentistry, pharmacy, physician assistant studies, physical therapy, occupational therapy, nurse anesthesia, cardiovascular perfusion, podiatry, optometry, clinical psychology, speech language pathology, biomedical sciences and veterinary medicine. Over 500 full-time faculty members and 400 staff members are dedicated to the education and development of our students in an environment that encourages learning, respect for all members of the health care team, service, interdisciplinary scholarly activity, and personal growth.
We offer a comprehensive benefits package that includes medical, dental, and vision insurance plans as well as life insurance, short/long term disability and pet insurance. We offer flexible spending accounts including healthcare reimbursement and child/dependent care account. We offer a work life balance with competitive time off package including paid holiday’s, sick/flex days, personal days and vacation days. We offer a 403(b) retirement plan, tuition reimbursement, child care subsidy reimbursement program, identity theft protection and an employee assistance program. Wellness is important to us and we offer a wellness facility on-site with a fully equipped fitness facility.
Midwestern University is an Equal Opportunity/Affirmative Action employer that does not discriminate against an employee or applicant based upon race; color; religion; creed; national origin or ancestry; ethnicity; sex (including pregnancy); gender (including gender expressions, gender identity; and sexual orientation); marital status; age; disability; citizenship; past, current, or prospective service in the uniformed services; genetic information; or any other protected class, in accord with all federal, state and local laws, including 41 C.F.R. 60-1.4(a), 250.5(a), 300.5(a) and 741.5(a). Midwestern University complies with the Smoke-Free Arizona Act (A.R.S. 36-601.01) and the Smoke Free Illinois Act (410 ILCS 82/). Midwestern University complies with the Illinois Equal Pay Act of 2003 and Arizona Equal Pay Acts.
Qualifications
Skills
Preferred
+ Verbal Communication: Advanced
+ Written Communication: Advanced
+ Team/Customer Focused: Intermediate
+ Customer Service: Intermediate
Education
Required
+ Bachelors or better
Experience
Required
+ 3-5 years of experience related to clinical research.
Preferred
+ Experience working in a team and customer service oriented environment.
+ Previous experience working in a dental office or hospital setting in a clinical capacity
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Source : Midwestern University