Biopharma Educational Initiative: Mentorship Opportunity in Clinical Trial Sciences
Your Opportunity to
Mentor
Rutgers MS in Clinical Trial Sciences
Capstone Course Students
(Graduate Fieldwork or Project Experience Course)
Created March 2014 and updated May 2017 by
Lisa Palladino Kim
Director of Capstone / Lecturer
M.S. in Clinical Trial Sciences, BioPharma Educational Initiative
School of Health Professions
Rutgers, The State University of New Jersey, 65 Bergen St. Rm 160, Newark, NJ 07101-1709
Master’s Degree in Clinical Trial Sciences
•
Biopharma educational initiative is an Industry-University collaboration to provide online
education to those individuals who are either working in, or desire to join the biopharmaceutical
workforce
•
Program goals vary depending on track chosen
•
All students will be able to:
•
Describe:
•
Drug development process
•
Identify and edit elements of a protocol
•
Explain research designs
•
Learn to apply
•
Ethical principles to the development and conduct of clinical trials
•
Interpret regulatory documents.
2
Courses in each Specialization track
•
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d
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c
r
u
i
t
m
e
n
t
•
Multiple Analyses in Clinical Trials
•
Overview of Disease Process and Treatment
•
Applied Clinical Trials & Good Clinical Practices
•
Biomedical Informatics for Clinical Trials
•
Principles of Subject Recruitment and Retention
•
Clinical Operations
•
M
e
d
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c
a
l
A
f
f
a
i
r
s
T
r
a
c
k
•
Overview of Disease Process and Treatment
•
Applied Clinical Trials & Good Clinical Practices
•
International Regulatory Affairs
•
Special Topics in Biomedical Informatics
•
Advertising & Labeling in Pharmaceutical
Medicine
•
Special Topics in Clinical Trial Sciences
•
Strategy, Insight Generation and Patient Journey
•
The Practice of Medical Affairs
•
Biopharma Educational Leadership Program
•
R
e
g
u
l
a
t
o
r
y
A
f
f
a
i
r
s
•
Multiple Analyses in Clinical Trials
•
Concepts of GxPs and Quality Assurance
•
Regulatory Writing for Submissions and
Publication
•
International Regulatory Affairs
•
Adverse Event Reporting & Postmarketing
Activities
•
Regulatory Requirements for Medical Devices
•
D
r
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g
S
a
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y
a
n
d
P
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m
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c
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v
i
g
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l
a
n
c
e
•
Multiple Analyses in Clinical Trials
•
Overview of Disease Process and Treatment
•
Adverse Events Reporting and Post marketing
•
Principles of Pharmacovigilance: Regulations &
Drug Safety Reporting
•
Risk Management Tools
•
Pharmacoepidemiology
•
Signal Detection & Quantifying Risk
•
Clinical Pharmacology
•
Analyzing Clinical Data for Adverse Events
(Elective)
4
I wish I could find
somebody to
investigate and
compare new
technologies for my
department?
FDA just released a
new guidance, I
wonder how that
will impact our
deliverables and
cycle time?
We would love to
create a white paper on
how patients can
provide protocol
feasibility insight.
We just developed a
new process, now we
need to create an
implementation plan
and training program.
Should our
department start
tracking AEs related
to birth if the study
subject was a male
instead of a female?
Final Course Requirement for Graduation
Intended to provide students with the opportunity to perform a prospectively planned research,
educational, administrative, or community service activity that will enhance their ability to either
apply their knowledge to real-life situations or to further their knowledge through in-depth
research on a topic of interest.
Students have three options for completing this requirement:
1. Research and write a scholarly paper with advisement from the faculty
2. Perform a project at their place of employment under the guidance of a preceptor
3
.
P
e
r
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.
The fieldwork option provides:
•
An opportunity for students to integrate knowledge and skills acquired throughout the program
in a practice setting intricately involved in drug development.
•
Individualized experiences based on identified goals and competencies, and the student’s
specialization track.
•
Flexibility to accommodate our working students (on-site or remote placements)
5
Fieldwork/Project Mentorship Experience Overall
•
Students would work closely with their preceptor (you or your colleague) to produce a
project plan and one or two main deliverable(s) or perform daily departmental duties.
(Research/white paper, oral presentation or webinar, abstract & poster presentation
submitted to a conference, or organizational specific documents created from
scratch/without a template), through in-depth research.
•
The experience is designed to be flexible
•
Fieldwork/Project is on a topic of mutual interest
•
On-site or remote interaction/access
•
Typically up to approximately 270 hours over one (or two) semester(s)
•
Additional facts:
•
The experience is a non-paying position
•
Students will complete the HIPPA and CITI certifications
•
If your company requires, the student may complete Criminal Background Check, additional
immunizations, and confidentiality disclosure forms
•
Students are required to have a B- or better in ALL previous coursework if paired with an
outside organization
6
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Our students have:
•
Reconciled adverse events
•
Created source document templates for a protocol
•
Prepared an Investigator binder
•
Created a Research Data Repository
•
Identified patients at a sites database that are likely to experience disease progression and create a
diagnostic tool
•
Performed aspects of a study coordinator/assistant role
Our students investigated:
•
Understanding and implementing Clinical Trial Management Systems to their fullest potential
•
Informed Consent in Pediatric Research
•
Bridging the Gap of Challenges and Issues related to Adaptive Design for Clinical Trials
•
Humanitarian Use Devices
•
Improving Minority Participation for Recruitment in Clinical Trials
•
Co-Development of Personalized Medicine and In Vitro Diagnostic Companion Devices
7
8
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1.
Decide if your company is interested in this opportunity
2.
Proactively work with Rutgers MS in CTS Director of Capstone to:
–
Ensure standard contract is legal and/or human resource approved
–
Edits to the standard language will require Rutgers legal agreement (this
requires time)
–
Identify the types of opportunities available (logistics, topics, interests) so Rutgers
can identify a student to match opportunity
3.
When a match is identified (normally one semester prior to start of student
experience),
–
Provide assistance to define measurable student objectives, scope of work, and
site specific deliverables
–
Finalize contract with specific students objectives (legal contract must be signed
with site prior to the first day of the students experience)
4.
Provide field mentorship to student during semester
What does this mean to you?
Example of standard non-clinical field mentorship contract
We also have a clinical field mentorship contract if students will be interacting with subjects/patients.
9
Roles during the semester
During the semester, students would work closely with their assigned course content advisor and
preceptor (you or your colleague) to produce a project plan and one or two main deliverable(s)
(research/white paper, oral presentation or webinar, abstract & poster presentation submitted to a
conference, or organizational specific documents created from scratch/without a template),
through in-depth research. They may even perform daily departmental duties.
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10
We look forward to developing this
amazing opportunity!
Any questions, please contact:
L
i
s
a
P
a
l
l
a
d
i
n
o
K
i
m
Director of Capstone / Lecturer
Mobile
484-686-0896
lisapalladinokim@rutgers.edu
Website:
http://shp.rutgers.edu/dept/biopharma/index.html
11
Industry-University collaboration offering a Master's Degree in Clinical Trial Sciences with specialization tracks in Clinical Trial Management, Regulatory Affairs, Drug Safety, and Medical Affairs. Courses cover topics such as drug development, protocol editing, research designs, ethical principles, and regulatory documents.
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The Biopharma Educational Initiative An Industry & University Collaboration Your Opportunity to Mentor Rutgers MS in Clinical Trial Sciences Capstone Course Students (Graduate Fieldwork or Project Experience Course) Created March 2014 and updated May 2017 by Lisa Palladino Kim Director of Capstone / Lecturer M.S. in Clinical Trial Sciences, BioPharma Educational Initiative School of Health Professions Rutgers, The State University of New Jersey, 65 Bergen St. Rm 160, Newark, NJ 07101-1709 E-mail lisapalladinokim@rutgers.edu
The Biopharma Educational Initiative An Industry & University Collaboration Master s Degree in Clinical Trial Sciences Biopharma educational initiative is an Industry-University collaboration to provide online education to those individuals who are either working in, or desire to join the biopharmaceutical workforce Program goals vary depending on track chosen All students will be able to: Describe: Drug development process Identify and edit elements of a protocol Explain research designs Learn to apply Ethical principles to the development and conduct of clinical trials Interpret regulatory documents. Total of 36 credits 4 specialization tracks (27 credits): Clinical Trial Management and Recruitment Regulatory Affairs Drug Safety and Pharmacovigilance Medical Affairs Core content (9 credits): Clinical Trial Overview: Methods and Practice Regulatory and Ethical Requirements Capstone Course or Evidenced Based Literature Review 2
The Biopharma Educational Initiative An Industry & University Collaboration Courses in each Specialization track Regulatory Affairs Multiple Analyses in Clinical Trials Concepts of GxPs and Quality Assurance Regulatory Writing for Submissions and Publication International Regulatory Affairs Adverse Event Reporting & Postmarketing Activities Regulatory Requirements for Medical Devices Clinical Trial Management and Recruitment Multiple Analyses in Clinical Trials Overview of Disease Process and Treatment Applied Clinical Trials & Good Clinical Practices Biomedical Informatics for Clinical Trials Principles of Subject Recruitment and Retention Clinical Operations Medical Affairs Track Overview of Disease Process and Treatment Applied Clinical Trials & Good Clinical Practices International Regulatory Affairs Special Topics in Biomedical Informatics Advertising & Labeling in Pharmaceutical Medicine Special Topics in Clinical Trial Sciences Strategy, Insight Generation and Patient Journey The Practice of Medical Affairs Biopharma Educational Leadership Program Drug Safety and Pharmacovigilance Multiple Analyses in Clinical Trials Overview of Disease Process and Treatment Adverse Events Reporting and Post marketing Principles of Pharmacovigilance: Regulations & Drug Safety Reporting Risk Management Tools Pharmacoepidemiology Signal Detection & Quantifying Risk Clinical Pharmacology Analyzing Clinical Data for Adverse Events (Elective)
The Biopharma Educational Initiative An Industry & University Collaboration Should our department start tracking AEs related to birth if the study subject was a male instead of a female? I wish I could find somebody to investigate and compare new technologies for my department? We would love to create a white paper on how patients can provide protocol feasibility insight. FDA just released a new guidance, I wonder how that will impact our deliverables and cycle time? We just developed a new process, now we need to create an implementation plan and training program. Students from a field mentorship program could be an asset to my organization. I wonder who I can partner with regarding a field mentorship program? 4
The Biopharma Educational Initiative An Industry & University Collaboration Final Course Requirement for Graduation Intended to provide students with the opportunity to perform a prospectively planned research, educational, administrative, or community service activity that will enhance their ability to either apply their knowledge to real-life situations or to further their knowledge through in-depth research on a topic of interest. Students have three options for completing this requirement: 1. Research and write a scholarly paper with advisement from the faculty 2. Perform a project at their place of employment under the guidance of a preceptor 3. Perform a mentored fieldwork/project experience with an outside organization. Your Opportunity The fieldwork option provides: An opportunity for students to integrate knowledge and skills acquired throughout the program in a practice setting intricately involved in drug development. Individualized experiences based on identified goals and competencies, and the student s specialization track. Flexibility to accommodate our working students (on-site or remote placements) You have an opportunity! Students can be a real asset to an organization, bringing enthusiasm and knowledge of the latest and greatest best practices. 5
The Biopharma Educational Initiative An Industry & University Collaboration Fieldwork/Project Mentorship Experience Overall Students would work closely with their preceptor (you or your colleague) to produce a project plan and one or two main deliverable(s) or perform daily departmental duties. (Research/white paper, oral presentation or webinar, abstract & poster presentation submitted to a conference, or organizational specific documents created from scratch/without a template), through in-depth research. The experience is designed to be flexible Fieldwork/Project is on a topic of mutual interest On-site or remote interaction/access Typically up to approximately 270 hours over one (or two) semester(s) Additional facts: The experience is a non-paying position Students will complete the HIPPA and CITI certifications If your company requires, the student may complete Criminal Background Check, additional immunizations, and confidentiality disclosure forms Students are required to have a B- or better in ALL previous coursework if paired with an outside organization 6
The Biopharma Educational Initiative An Industry & University Collaboration Rutgers has placed students with clinical study sites, IRBs, CROs, service providers, advocacy foundations, and pharmaceutical companies. Our students have: Reconciled adverse events Created source document templates for a protocol Prepared an Investigator binder Created a Research Data Repository Identified patients at a sites database that are likely to experience disease progression and create a diagnostic tool Performed aspects of a study coordinator/assistant role Our students investigated: Understanding and implementing Clinical Trial Management Systems to their fullest potential Informed Consent in Pediatric Research Bridging the Gap of Challenges and Issues related to Adaptive Design for Clinical Trials Humanitarian Use Devices Improving Minority Participation for Recruitment in Clinical Trials Co-Development of Personalized Medicine and In Vitro Diagnostic Companion Devices What can our students investigate for you? 7
The Biopharma Educational Initiative An Industry & University Collaboration What does this mean to you? 1. 2. Decide if your company is interested in this opportunity Proactively work with Rutgers MS in CTS Director of Capstone to: Ensure standard contract is legal and/or human resource approved Edits to the standard language will require Rutgers legal agreement (this requires time) Identify the types of opportunities available (logistics, topics, interests) so Rutgers can identify a student to match opportunity When a match is identified (normally one semester prior to start of student experience), Provide assistance to define measurable student objectives, scope of work, and site specific deliverables Finalize contract with specific students objectives (legal contract must be signed with site prior to the first day of the students experience) Provide field mentorship to student during semester 3. 4. Roles: Rutgers Capstone Director (Lisa Palladino Kim, lisapalladinokim@rutgers.edu ): Provides assistance in establishing a contractual relationship with the site and assisting with the development of project objectives per student. Preceptor (for students performing field mentorships): Provides assistance to define students objectives, scope or work, and site specific deliverables. Signs final contract. 8
The Biopharma Educational Initiative An Industry & University Collaboration Example of standard non-clinical field mentorship contract We also have a clinical field mentorship contract if students will be interacting with subjects/patients. 9
The Biopharma Educational Initiative An Industry & University Collaboration Roles during the semester During the semester, students would work closely with their assigned course content advisor and preceptor (you or your colleague) to produce a project plan and one or two main deliverable(s) (research/white paper, oral presentation or webinar, abstract & poster presentation submitted to a conference, or organizational specific documents created from scratch/without a template), through in-depth research. They may even perform daily departmental duties. Rutgers Course Content advisor: Rutgers faculty that provides high level guidance to student, addresses any conflicts or concerns that might arise, and periodically checks in with you regarding student s progress. Rutgers course content advisor will be responsible for grading the students main course deliverables. (Note, deliverables can be de-identified or Rutgers can sign your companies confidentiality disclosure agreement, if required.) Preceptor: Provides assistance to refine students objectives, scope or work, and site specific deliverables. Provides the most guidance on the students activities, project plan, and other deliverables. The Rutgers course content advisor s role is to make sure it is robust enough and scholarly for course credit. At the end of the semester, Rutgers will reach out to obtain your overall semester feedback, which translates into points and is counted towards the students grade. 10
The Biopharma Educational Initiative An Industry & University Collaboration We look forward to developing this amazing opportunity! Any questions, please contact: Lisa Palladino Kim Director of Capstone / Lecturer Mobile 484-686-0896 E-mail lisapalladinokim@rutgers.edu Website: http://shp.rutgers.edu/dept/biopharma/index.html 11
