Clinical Research Specialist - Central Maryland Oncology (Columbia, MD)
Facility: University of Maryland Medical Center
Employment Type: Full Time
Location: Baltimore, MD Shift/Schedule: DAY
Department: GCC: Central Md Oncology
Posted FTE: 1
Job Posting Category: Professionals
Hours of Work: 7-7
Job ID #: 41415
Benefits Eligible: Yes
Minimum Education: Bachelor's in related field of study
License/Cert Required: Not Indicated
Minimum Experience: 3 years of relevant research experience
Specialty Type: Radiation Oncology
What You Will Do:
Under general supervision, coordinates the implementation of research protocols approved for activation at the University of Maryland Medical System. Participates in complex clinical trial; ability to work independently. Acts as a resource to the Clinical Research Coordinators
Principal Responsibilities and Tasks
The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all job duties performed by personnel so classified.
1. Submit protocols through appropriate review boards. Interface with relevant groups, industry sponsors, patients, physicians, or other members of the health care team.
2. Recruit and screen subjects for research studies.
3. Perform and direct studies and/or project(s). Develop, recommend, modify and implement policies and procedures and/or methods for clinical research. Develop protocol manuals and data collection instruments.
4. Perform clinical research activities including data collection, data entry, data verification, data analysis, compliance and clinical relevance of data. Conduct library research and contributes to the preparation and writing of research findings for publication of journal articles and grant proposals.
5. Perform administrative duties such as providing training and guidance to other clinical research staff.
6. Participate in the design of research studies
7. Anticipates and carries out independent actions necessary to provide competent and professional support to meet the needs of the faculty physicians, patients, administrators, co-workers, and others involved with clinical trials. Acts as a resource to investigators, faculty physicians and clinical research coordinators.
8. Acts as liaison between the institution and the study sponsor by preparing study reports and communicating with clinical study monitors.
9. Ensure that research is conducted according to Good Clinical Practices, Quality Assurance and Code of Federal Regulations as well as prepare protocols, consent forms, and all accompanying documents for submission to the departmental, IRB and internal/external review entities
10. Maintains clinical database(s) on patients participating in clinical studies and/or seen by a specific clinical service and oversees data entry by data management staff.
11. Oversees interaction with study participants, ensuring informed consent and compliance with protocol; monitoring subject symptoms; managing continuity of care.
12. Assists clinical investigator with study initiation, conduction, and completion.
a. Communicates with the Institutional Review Board (IRB) and other departmental review committees.
b. Acts as a consultant to members of the health care team.
c. Educates faculty and hospital staff by providing written and oral presentations related to protocol treatment administration and procedures.
d. Communicates treatment modifications and amendments to faculty and staff.
e. Prepares study results for presentation and/or publication.
11. Prepares and responds to audits conducted by study sponsors.
12. Acts as a resource for the Clinical Research Coordinators.
13. Represents department at research and protocol initiation meetings.
What You Need to Be Successful:
Education and Experience
1. Bachelor’s degree in epidemiology, sociology, psychology, nursing or field of study related to the research of the clinic.
2. Three (3) years experience in clinical research including two (2) years in the relevant research specialization.
3. Consideration may be given for a unique combination of education and experience.*
4. May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials and/or ionizing radiation.
Knowledge, Skills and Abilities
1. Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
2. Ability to take a lead role in performing and directing various advanced, routine, and maintenance procedures.
3. Ability to perform independent projects and to serve as a consultant in area of technical specialty.
4. Ability to use measurable and verifiable information for making decisions or judgments.
5. Skill in statistical programming, interpretation and data analysis using statistical software as well as spreadsheet and database software applications.
6. Ability to apply knowledge of scientific theory and computer capability to design and recommend changes to methods for clinical research.
7. Ability to network with, and present information to key groups and individuals.
8. Ability to conduct library research and participate in the preparation of journal articles.
9. Ability to complete and administer complex research protocols.
10. Knowledge of best practice in Clinical Research.
~CB
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Facility: University of Maryland Medical Center
Employment Type: Full Time
Location: Baltimore, MD Shift/Schedule: DAY
Department: GCC: Central Md Oncology
Posted FTE: 1
Job Posting Category: Professionals
Hours of Work: 7-7
Job ID #: 41415
Benefits Eligible: Yes
Minimum Education: Bachelor's in related field of study
License/Cert Required: Not Indicated
Minimum Experience: 3 years of relevant research experience
Specialty Type: Radiation Oncology
What You Will Do:
Under general supervision, coordinates the implementation of research protocols approved for activation at the University of Maryland Medical System. Participates in complex clinical trial; ability to work independently. Acts as a resource to the Clinical Research Coordinators
Principal Responsibilities and Tasks
The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all job duties performed by personnel so classified.
1. Submit protocols through appropriate review boards. Interface with relevant groups, industry sponsors, patients, physicians, or other members of the health care team.
2. Recruit and screen subjects for research studies.
3. Perform and direct studies and/or project(s). Develop, recommend, modify and implement policies and procedures and/or methods for clinical research. Develop protocol manuals and data collection instruments.
4. Perform clinical research activities including data collection, data entry, data verification, data analysis, compliance and clinical relevance of data. Conduct library research and contributes to the preparation and writing of research findings for publication of journal articles and grant proposals.
5. Perform administrative duties such as providing training and guidance to other clinical research staff.
6. Participate in the design of research studies
7. Anticipates and carries out independent actions necessary to provide competent and professional support to meet the needs of the faculty physicians, patients, administrators, co-workers, and others involved with clinical trials. Acts as a resource to investigators, faculty physicians and clinical research coordinators.
8. Acts as liaison between the institution and the study sponsor by preparing study reports and communicating with clinical study monitors.
9. Ensure that research is conducted according to Good Clinical Practices, Quality Assurance and Code of Federal Regulations as well as prepare protocols, consent forms, and all accompanying documents for submission to the departmental, IRB and internal/external review entities
10. Maintains clinical database(s) on patients participating in clinical studies and/or seen by a specific clinical service and oversees data entry by data management staff.
11. Oversees interaction with study participants, ensuring informed consent and compliance with protocol; monitoring subject symptoms; managing continuity of care.
12. Assists clinical investigator with study initiation, conduction, and completion.
a. Communicates with the Institutional Review Board (IRB) and other departmental review committees.
b. Acts as a consultant to members of the health care team.
c. Educates faculty and hospital staff by providing written and oral presentations related to protocol treatment administration and procedures.
d. Communicates treatment modifications and amendments to faculty and staff.
e. Prepares study results for presentation and/or publication.
11. Prepares and responds to audits conducted by study sponsors.
12. Acts as a resource for the Clinical Research Coordinators.
13. Represents department at research and protocol initiation meetings.
What You Need to Be Successful:
Education and Experience
1. Bachelor’s degree in epidemiology, sociology, psychology, nursing or field of study related to the research of the clinic.
2. Three (3) years experience in clinical research including two (2) years in the relevant research specialization.
3. Consideration may be given for a unique combination of education and experience.*
4. May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials and/or ionizing radiation.
Knowledge, Skills and Abilities
1. Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
2. Ability to take a lead role in performing and directing various advanced, routine, and maintenance procedures.
3. Ability to perform independent projects and to serve as a consultant in area of technical specialty.
4. Ability to use measurable and verifiable information for making decisions or judgments.
5. Skill in statistical programming, interpretation and data analysis using statistical software as well as spreadsheet and database software applications.
6. Ability to apply knowledge of scientific theory and computer capability to design and recommend changes to methods for clinical research.
7. Ability to network with, and present information to key groups and individuals.
8. Ability to conduct library research and participate in the preparation of journal articles.
9. Ability to complete and administer complex research protocols.
10. Knowledge of best practice in Clinical Research.
~CB
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.