This position will work with the RePORT-Brazil observational cohort, which includes data and specimen repositories from TB patients and their close contacts in Brazil: Rio de Janeiro, Salvador, and Manaus. He/she must be proficient/fluent in Portuguese and have experience in conducting i nternational research. The work involves daily communication with investigators and site coordinators, as well as laboratory staff in Brazil , and require staff to make several trips to Brazil each year. Staff will also have budgetary responsibilities, management of subcontract administration, and assisting with the development, processing and writing of grants.
1 ) IRB submission: Coordinate the administrative efforts in identifying, creating and preparing regulatory submissions for the Project Pl and other faculty in the RePORT Brazil cohort. This includes IRB submissions at Vanderbilt and in Brazil , for the primary project and also scientific sub studies.
2) Development and maintenance of project database:
Ensure that data collected are harmonized with data collected from other countries engaged in the TB cohort study.
Continuously compile, r eview and analyze data entered into REDCap, in order to ensure Data Quality, including onsite review of primary so urce document s . This i s required for the Data Completion and Quality Plan.
Work closely with Data Manager to extract and analyze meaningful information from the database for the investigators gran t applications and publication s.
Create new variables and Case Report forms as needed.
3) Maintenance of the Biorepository:
Ensure that the project's biorepository consistently follows the best practices for biorepositories, i ncluding collection, tran s port, storage a nd retri eval of specime ns collected in the RePORT Brazil cohorts.
Manage s p ec imen inventory and s upervi se Biorepository coordinator ' s activities.
Oversee ca pacity status, equipment and s upplie s purcha ses .
En s ure specimen quality throu g h internal assessments.
Oversee laboratories activities: Marina is in daily communication with the immunolo gy and microbiology laboratorie s to make sure they have the necessary re age nts, s upplies and training to perform all the lab activiti es re quired and described in the project 's SOPs and Lab Manual.This include s interaction s with Duke Universit y (PBMC s ), SMILE Program (mi cro biology) and Westat.
Oversee enrollment sites activities:
Supervise enrollment in each clinical s ite , in order to comply with what was proposed i n the project's de s cription .
Prevent and/or identify potential problem s that affect pa rticip a nt enrollment.
On s it e QA and review of consent forms and as sessi ng for data quality and completion.
Meeti ngs and travels :
He/she will organize and participate in conferen c e calls with investigators, potential collaborators , lab and c linical per s onnel, as well as RePORT Intern a tional Coordinating Center and funding agencies.
He/sh e will also go to Bra z il at least 4 time s a year to coordinate our sem i-an nual R e PORT Br azi l meetings and al so to do site monitoring visits (Ri o de Janei ro, Manaus and Salvador) .
Training: he/ s he will provid e training of s tudy s taff when needed o r w hen we add a new proto co l.
Purchases : He/she will ov e r see and coo rdin ate RePORT-Brazil co ho r t with ordering proce ss i n Bra zi l and at Vanderbilt.
Write grant do c ument s as well as sup portin g do cuments a nd assis t i ng wi th dev e l opment of grant docum e nt s for s ubmi ss ion .
D eve lop bud ge t s for gra nts, s uppl e m e nt r eq u es t s, con tra cts or other funding r e que s t s ; co ordin ate preparation of appropriate forms;
Perform pre -a nd po s t - award activities p e r NIH or other spo n s orin g i n st i tution s.
M a n age assigned s ub-contract s to th e si t es i n Brazil. Serve as fi scal l ia i son, repr ese nting th e proj ec t to investigators, Vanderbilt ad mi nis t rat ion , and admin is tr a ti ve staff at the collaborating in s titution s.
Pr e pare budget proje c tion s and r ev iew applications s ubmitted for grant fundin g .
Pr e par e annual g r an t r e port s to funding agencies.
Monitor expenditures against budget; prepare nece ssary documentation for s upervi so ry review /a pproval ; tabulate/analyze budgetary data, calculate figur es , and check for accuracy .
Manage and track subcontract direct charges, invoices; help withannual close outs and reporting for active re sea rch grants as forRePORT and other related awards.
Regulatory documents: deve l opment and maintenance ofCase report forms, Protocol , Informed consent and assent form s, Laboratory Manual, Biorepository Contingency Plan , Lab/Clinical/Biorepository SOPs , Reporting of Adverse events, etc.
Communication: In English and in Portugue se (verbal andwritten). Communications with the principal investigators, study staff, l ab staff, Biorepository pe rsonnel, FIOTEC/NIH , RICC, Brazilian National TBProgram, Brazilian Ministry of Health , Vanderbilt administration and grants per so nnel, Finance , OSP , MTA/legal.
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