Managing Research Projects: A Comprehensive Guide
Comprehensive guide on successfully managing research projects from proposal to closeout. Learn how to set yourself and your PI up for success, handle challenges, and navigate the project lifecycle effectively.
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LEADING YOUR PI TO SUCCESS: Managing Research Projects from Proposal through Closeout
Goals of Todays Session: A Case Study for Setting yourself and your PI up for success From proposal through closeout . And handling sticky situations along the way .
Getting Started: Ask the right questions When is it due? Who is the sponsor?/RFA# or instructions Are there external collaborators? Are their human subjects? Who is the PI? What is the project?
The Case Study We are preparing a multi-faceted NIH application: - Partnership between 3 institutions; 1 in Mexico - GMP at 4th institution added in year 3 - Total budget is limited to $5 million ( $1 mil/yr). - Multi PI - Simple clinical study, 1 blood draw, 300 patients
Define Responsibilities PI Department OSR Anyone else? Go Team!
Arm yourself with Info and Qs Read the RFA/Instructions - ID the usual and THE UNUSUAL - Know the budget limitations - Note your questions for the PI
Make a plan Work backwards from due date Fill in dept/non-science items first Expandor contrast into the time available 5 days, 5 weeks, or 5 months The shorter the time the more help you will need. Set rules but be flexible Long lead times first Sub documents, quotes, clinical pricing
Sample Timeline for Junior Faculty RFA # OSR Proposal Deadline: XX/XX/XXXX, time Sponsor Proposal Deadline: XX/XX/XXXX, time Week of: Action Item Getting Started Responsibility Due Date Proposal Notification Form Download and complete Application Package (fillable forms)/or initiate proposal on sponsor website Identify Sr/Key Personnel and main budget categories/amounts Identify letters of support needed Send Subaward Proposal Packet to Subaward PI (Set return deadline 1 week before sponsor deadline) Requests quotes/pricing Complete Proposal Attachments Introduction (for Resubmissions only) Abstract Specific Aims Research Strategy Cover letter Bibliography and References Resources and Environment Equipment (description of what is available) Human Subjects Women and Minorities Attachment Children Vertebrate Animals Cover letter Biosketches Other support documents Budget Budget Justification Complete Internal Doucments and Route for Signatures Dept Dept PI PI C PI PI PI PI PI PI PI PI PI PI PI PI PI Dept Dept Dept Dept Internal Routing Form PI Eligibility Form IDC Waiver Finalizing the Proposal Dept Dept Dept Obtain all subaward dcouments Assemble proposal with all attachments Final PI review Submit Proposal and PDAF to OSR Submit Proposal Dept Dept PI Dept OSR Science Non-Science Completed C SUB COLLABORATORS
Sample Timeline for Sr/Experienced PI Investigator RFA-PM-16-004 timeline Proposal Deadline: 2/4/17, 5:00 PM Week of: 12/14 12/21 12/28 C Action Item Proposal Notification Form Send out request for sub documents Draft Specific Aims and Circulate to scientific team Download and complete Application Package (fillable forms) LOI due to NIH (Title, PI's, list of all key persons) First draft of science ready for review Planned enrollment Table - phase 1 (10,000 saliva samples) Planned enrollment Table - Phase 2a (1 million blood/urine samples) Sub Documents due back Draft Budget (1 budget for all 3 phases) Draft budget justification (break non-personnel into the 3 phases) Near final draft of scientific components due Supporting documents (Biosketches, facilities, letters of support, Human Subjects, Resource Sharing/GWAS, Multi PI leadership) Final Science Components Finalize budget and budget justification PDAF All materials to OSR Submit Proposal Responsibility Dept OSR PI Dept Dept PI PI PI OSR Dept Dept PI Due Date 1/4 1/11 1/18 1/25 2/1 Dept/PI PI Dept/PI/OSR Dept Dept OSR Science Non-Science Completed SUB COLLABORATORS Fisher Biosciences C
Get everyone on board Create an email to PI -Outline who will do what with timeline -Consider PI level and experience -Be prepared to modify your template based on the RFA and the PI -Include your PI questions from the RFA -Decide level of assistance needed from OSR/others -Ask PI to agree to the plan
Create an email to PI Hint: in the email subject, always state what you need. For example: URGENT: NIH Proposal - Info needed from you to proceed Dear Dr. X I have reviewed the RFA for your application due XX/XX/XXXX. Attached is a plan outlining what needs to be completed, by whom and by when so that we can meet the deadline. Please confirm that this plan is acceptable. In addition, please provide the following by XX/XX: (list your questions and immediate needs): 1. Collaborator name and contact info at [sub institution name] 2. Enrollment plan by site by year. 3. List of employees/Investigators who will work on project with project role and estimated effort. I am scheduling a meeting for us on XX/XX/XXXX to discuss and finalize the budget and justification. Happy to address any questions you may have about specific sections or the proposal preparation process.
Keep frustrations to a minimum all around Develop a tool kit Templates of emails, budgets, forms Use your calendar/reminders/tasks Work the plan Touch base 1 week and 1 day before something is due. Let the PI write Scheduled, targeted meetings/talks
Working with Subs Be clear about what you need from your PI and what you need from the subs: - Have you worked with them before? - Contact info? - Have the PI s worked together before? - Budget Target? - Draft email template with specific list of required documents and due dates. Foreign sites or smaller institutions may need additional assistance/guidance.
Working with Subs Email to sub: Dr. Smith has agreed to participate as a PI on Dr. Brown s grant proposal that is due to NIH on XX/XX/XXXX. Please provide the following sub contract documents for Research University by XX/XX/XXXX: Dr. Smith and Dr. Brown have agreed that Dr. Brown s effort will be 20% for all years. Project Title: Drug Development and Precision Medicine Training: A UCR-CoH partnership Program P20 PAR-16-084 https://grants.nih.gov/grants/guide/pa-files/PAR-16-084.html Announcement Project Period: 09/01/2017-08/31/2021 - - - - - Signed letter of intent to enter into a consortium (attached) Complete attachment 3B (attached) Detailed budget not to exceed $200,000 total per year Biosketch for Dr. Brown and any other key personnel Sr./Key Profile information (attached worksheet)
Prime Personnel / Fringe PI Co-I Post Doc Clinical Coord yr 1 yr 2 yr 3 yr 4 yr 5 TOTAL 20% 15% 50% 100% 167,050 20,000 46,800 29,250 167,050 20,000 46,800 29,250 46,800 29,250 78,000 91,000 245,050 20,000 20,000 154,050 20,000 46,800 29,250 78,000 154,050 20,000 46,800 29,250 78,000 234,000 146,250 234,000 273,000 887,250 100,000 20,000 2,500 25,000 - - 91,000 91,000 - - Supplies Equipment Patient Care Travel Other Stipends Publication DIRECT IDC Prime @60% IDC Subs PRIME TOTAL BUDGET - 500 - - - - - 20/40/40 @ $25 1,000 5,000 1,000 5,000 5,000 5,000 5,000 20/40/40 @ 10 194,750 116,550 45,000 356,300 200 195,450 116,670 312,120 400 293,450 163,470 15,000 471,920 400 181,050 108,630 289,680 - 181,050 108,630 289,680 - 1,000 10,000 1,045,750 613,950 60,000 1,719,700 2,000 2,000 2,000 2,000 2,000 - - - Sub 1 Sub 2 Sub 3 - Mexico Sub 4 - GMP GRAND TOTAL BUDGET 15/25/30 @ $25 10/25/30 @ $25 10/25/30 @$25 200,000 190,000 150,000 200,000 190,000 150,000 200,000 190,000 150,000 150,000 1,161,920 200,000 190,000 150,000 300,000 1,129,680 200,000 190,000 150,000 130,000 959,680 1,000,000 950,000 750,000 580,000 4,999,700 896,300 852,120
Nice work Doris. I have another one to submit in two weeks.
Its here, Its here! Yippie! 4 months after submitting JIT documents, we receive the Notice of Award It has a 14% budget cut and requires quarterly reporting.
What races through your mind? 1. Need to revise the budget - What do we cut? - Are Specific Aims affected? - Is enrollment affected? - Is effort reduced for anyone? 2. Sub-Awards - Strict schedule for reporting and invoicing - Risk level for Mexico
Helping yourself and your PI: - Offer budget options - Discuss with PI frequency for communicating with Subs - Set up reminders for yourself to contact subs for invoices/reports. - The telephone is an amazing tool.
Preventative Maintenance: - Know your terms and conditions - Be Proactive - Effort Distribution - Reconcile and Analyze - Check the burn rate - Check in with your PI - Verify expenses are appropriate - When in doubt, ask for help
Manage the subs: Make sure the PI s know their responsibilities Know how to identify an issue with a sub, more importantly who can help resolve? OSR, PI s, legal? Find your administrative partner at the sub site.
If you have been proactive and timely, closeout will be easy: Start 60-90 days before end date Again, contact subs that it is ending, invoices current Plan where all your personnel are moving to before the last day Clear outstanding obligations, encumbrances, blanket PO s Don t order anything in the last month Finalize the reconciliation Make sure PI knows deadlines for final report and invention statement Work closely with your grants accounting for FSR
Leading you and your PI to success: Stick to the plan Be proactive Strong relationships with your sub partners ID issues early Then everyone is happy.
