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Research Program Leader Resume Example

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Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Summary
20 years clinical research experience in ophthalmic research, developed, coordinated, and implemented effective research and administrative strategies for all phases of clinical trials research   in accordance with international, federal, state and ICH guidelines as well as ophthalmic and genetic biorepository management 
Education and Training
Duke University Durham, NC Expected in September 2010 Masters : Health Sciences, Clinical Research - GPA : Health Sciences, Clinical Research
Santo Tomas University Hospital Manila, Expected in December 1997 Residency Training Ophthalmology : - GPA : Internship Most Outstanding Intern
University of Santo Tomas Manila, Expected in April 1992 Doctor of Medicine : - GPA :
University of Santo Tomas Manila, Expected in March 1988 Bachelor of Science : Microbiology - GPA : Microbiology Cum Laude
Experience
- Research Program Leader
, , 07/2016 - Present
  • Provided operational leadership for the development of the first eye and tissue biobank and repository program and shared resource/core service at Duke Served as an internal expert resource regarding various operational issues including ethical conduct of program and safety issues Developed SOPs and implemented the operational approaches to provide local eye researchers rapid real time donor tissue assessment and phenotyping, specifically including tissue examination to confirm ocular diagnoses as well as tissue preparation strategies for immediate use or banked tissues Coordinated with sponsors (Miracles in Sight, Donate Life NC, Foundation Fighting Blindness) in creating programs that can educate and inform researchers community eye care providers and the general public about eye donation Served as the primary point of contact for the BioSight Core program Utilized "Lean process" technique for program development Personnel Management Maintained working relationships and communications with Duke Biobanking programs, program sponsors (Miracles in Sight, Donate Life NC) and other departments at Duke such as Office of the Associate Dean Space Management and Research Resources and Office of Research Collaborations Instrumental in establishing research relationships with collaborators at Duke, community eye care providers such as optometrists and basic science researchers and clinicians throughout the US Trained and oriented basic science research personnel, clinical associates, investigators to promote BioSight Core program Provided field training for new hires and personnel needing training in the basic science laboratory and in the Ophthalmology Clinical Research Unit as directed by the Ophthalmology Vice Chair of Research and Assistant Director of the CRU Performed quality assurance, monitoring review and audits for various studies as requested by the Ophthalmology Vice Chair of Research and CRU Directors to ensure institutional conformity, generated queries and recommended corrective action plans.
  • Continued to support the Ophthalmology CRU for various roles as directed by the Ophthalmology Vice Chair of Research, CRU Directors, and PIs.
  • Financial Management Lead investigators to research funding resources and provided instrumental support obtaining initial funding for this BioSight project Reconciled, maintained inventory listing and audited fund code associated with grant/ fund code/s Created Profit and Loss, Shared Resource worksheets and worked with financial managers to create the business plan for the BioSight "core" application Served as support staff for the CRU RFPM in creating study budget and budget negotiation/s for industry sponsored project/s Protocol Development Worked alongside with the program faculty investigators in creating the objectives and the development of the first Duke eye bank and biorepository research program Conducted investigations of current eye banking and repository trends and recommended to faculty directors strategies that could be implemented for the program Created timelines and strategies to meet immediate goals of the program Reported to faculty directors provided report updates and effectiveness of strategies Created advertising materials (i.e.
  • pamphlets, posters, tv monitor ads) and worked with Duke Research Innovations Center for the promotion of the BioSight program Instrumental in modification of various web interfaces including Donate Life NC to incorporate the BioSight program Created the RedCap electronic data tool for BioSight program Collaborated with existing facilities at Duke to integrate BioSight to the CoreResearch @Duke for Biobanking to maintain a sample inventory, management and allocation system (Labvantage)and integration of BioSight to the Duke Biobank Index of Specimens (in process) Continued to serve the Ophthalmology CRU as an expert resource for fellows, visiting post docs, investigators in the feasibility planning, development of complex multisite projects, budget planning, budget justification and negotiations.
  • Continued to serve as an expert resource in creating ophthalmic databases/registry in RedCap such as MIGS database.
-
, , 04/2000 - 07/2016
  • Clinical Research Program Coordinator Duke Eye Center Clinical Research Unit Project Management and Operations Managed overall operations for ophthalmic genetics research, health services, and epidemiology studies local and international ( North America, Africa and Asia) Managed all multiple industry sponsored studies in Ophthalmology (clinical drugs and device) including 25-30 secondary studies needing ophthalmic exams from the different divisions in the Duke Medical Center (Oncology, Psychiatry, GI Medicine, Neurology, Cardiology, Anesthesiology) Created guidelines and SOPs for multiple studies and provided implementation plans and training of study staff Provided personnel evaluations for team members and suggested plans for personnel advancement and growth Served as the expert resource for the Ophthalmology CRU for project management, regulatory, and recruitment matters Trainer for the Duke Office of Clinical Research- Study Documentation classes attended by clinical trials assistants, clinical research coordinators, program leaders, and research medical staff Study start up Discussed and reviewed with principal investigators various proposals and protocols specifically to assess our site's ability to implement the protocol or feasibility of conducting the study elsewhere Participated in development of study protocols (investigator initiated, residents and fellows projects), consent forms, case report forms, study checklists and internal study monitoring tools for participants and study team Participated in site selection for international studies, managed research operations, trained study staff - investigators, coordinators, study assistants and data technicians ( recruitment, consenting, sample collection, data collection and shipment and provided assistance to complete research modules to continue collaboration with Duke ) Prepared and ensured availability of all study site requirements: personnel, resources, and offered resolutions/ corrective actions to multiple issues encountered by site Recommended recruitment strategy for both small (i.e.
  • investigator initiated , industry sponsored ) and large scale (i.e.
  • genetic/epidemiology) studies Reviewed journals, abstracts and scientific literature to obtain information regarding previous studies to aid in the planning of new studies Communicated with the IRB, sponsor, CRO, collaborating sites and submitted all regulatory requirements to regulatory agencies to obtain institutional approval for studies Active Phase Prepared and ensured adequate study documentation for all projects Ensured the smooth flow of all study related procedures and compliance to study protocol Conferred with study participants and explained the study, answered questions related to the study to alleviate study concerns (if any) Occasionally, performed physical exams related to the study delegated to the CRC including laboratory tests required i.e.
  • blood draws, visual field tests, blood pressure check, intraocular pressure check; documented procedures, followed up results, logged and filed results Performed calibration of test instruments (when required) and maintained a log of instrument calibration and or adjustments Created CRFs for paper and electronic systems such as RedCap Collected data form patient charts or medical records, interview, or questionnaires and completed the Case Report Forms (CRF) in paper and remote data entry systems such as Pedigene, and sponsor specific data entry systems and data base systems such as DEDUCE, DISCERN Communicated with the IRB, sponsor and regulating agencies and submitted all required amendments, continuing reviews, deviations and safety events Responded to queries and ensured all deficiencies and corrective action for deviations have been addressed in preparation for study close out Assisted in the preparation of oral, written reports for presentation or manuscript submission, and preparation of data for grant submissions Close out Submitted IRB documents for close out and organized all paper documents in preparation for long term storage Financial Agreements and Contracts Created and coordinated study agreements, MTA, DTA, financial agreements and played major role in budget negotiations for primary and secondary studies, and in the submission of various grants (i.e.
  • NIH, RPB grants) Reviewed and audited charges on study fund codes and accurately completed financial sheet related to the study.
  • Verified charges to study confirm subjects or insurance is not billed for study related costs.
  • In the absence of the RFPM) Assisted the PI and interim finance personnel in creating study budgets and played an instrumental role in budget negotiations Monitoring and Data analysis Prepared the study site for monitor visits and regulatory audits and assisted fellow coordinators for study audits Reviewed regulatory documents to ensure compliance with study protocol and Duke policies and guidelines, initiated corrective actions whenever appropriate (specifically PI initiated studies) Internally monitored studies to recognize and identify problems, inconsistencies with protocol, including adverse events documentation (specifically PI initiated studies) Coordinated with data technicians for the accurate entry of CRF's into the database.
  • Assisted in the evaluation and interpretation of clinical data as appropriate.
Duke University - Clinical Ophthalmic Assistant
, , 10/1998 - 04/2000
  • Assisted ophthalmologist and optometrist by examining patient's anterior segment using slit lamp Obtained medical and personal data from patient and medical chart Assisted patients in fitting contact lenses Performed visual acuity tests, refractions, central and visual field tests, color vision tests, pupil testing, intraocular pressure tests Provided safety instructions/precautions to patients after numbing eyes and after dilation Performed specific ophthalmology procedures as instructed by study coordinator for protocols needing specific eye evaluation Performed "call-backs" various eye related concerns/problems Prepared clinic rooms to be patient ready with adequate supplies and calibrated instruments.
Activities and Honors
1987-1988 President Microbiological Society University of Santo Tomas, Manila Member North Carolina Regulatory Affairs Forum (NCRAF) March 2018 Member Duke CTSI Project Management Community of Practice 2017
Publications
Journals Dawn, A, Santiago-Turla, C, Lee, P. Patient Expectations Regarding Eye Care. Archives of Ophthalmology, 121: 762-8, 2003. Allingham RR, Wiggs JL, Hauser EA, Larocque-Abramson KR, Santiago-Turla C, Broomer B, Del Bono EA, Graham FL, Haines JL, Pericak-Vance MA, Hauser MA. Early adult-onset POAG linked to 15q11-13 using ordered subsets analysis, Invest Ophthalmol Vis Sci, 46(6): 2002-5, 2005. Knepper, P, Miller A, Choi, J, Allingham R, Santiago, C et al. Hypo-Phosphorylation of Aqueous Humor sCD44 and Cell Death in Primary Open Angle Glaucoma, Invest Ophthalmol Vis Sci, in press. Muir K, Santiago-Turla C, Stinnett, S. et al. Health Literacy and Adherence to Glaucoma Therapy, Ophthalmology, 142:233-226, 2006. Arani S, Sarunic, M, Santiago C, Izatt J. Detailed Visualization of the Anterior Segment using Fourier Domain Optical Coherence Tomography. Arch Ophthalmol. 2008;126(6): Muir KW, Santiago-TurlaC, Stinnett SS, Herndon LW, Allingham RR, Challa P, Lee PP. Heath Literacy and vision-related quality of life. Br J Ophthalmol. 2008 Jun; 92(6) 779-82. Liu Y, Schmidt S, Qin X, Gibson J, Hutchins K, Santiago-Turla C, Wiggs JL, Budenz DL,Akafo S, Challa P, Herndon LW, Hauser MA, Allingham RR. Lack of association between LOXL1 variants and primary open-angle glaucoma in three different populations. Invest Ophthalmol Vis Sci.2008. Aug; 49 (8):3 465-8. Santiago-Turla C, Rivera-Francia MK, Navarro B, Eclarinal JJ, Dizon B, Francia P, Stinnett, S and Allingham RR. Assessment of visual status of the Aeta, a hunter-gatherer population of the Philppines. Philipp J Ophthalmol. 2008; 33(2):41-46. Liu Y, Akafo S, Santiago-Turla C, Cohen C, LaRocque-Abramson K, Qin X, Herndon L, Challa P, Schmidt S, Hauser M, Allingham, R. Optineurin coding variants in Ghanaian patients with primary open-angle glaucoma. Molecular Vision. 2008. Dec; 14: 2367-2372. Muir K, Santiago-Turla C, Stinnett S, Herndon L, Allingham R, Challa P, Lee. Glaucoma Patients' Trust in the Physician. Journal of Ophthamology. 2009. 1-5. McDonald K, Abramson K, Beltran M, Ramirez M, Alvarez M, Ventura A, Santiago-Turla C, Schmidt S, Hauser M, Allingham R. Myocilin and optineurin coding variants in Hispanics of Mexican descent with POAG. J Hum Genet. 2010.1-4. Asrani S, Chatterjee A, Wallace D, Santiago-Turla C, Stinnett S. Evaluation of the ICare Rebound Tonometer as a Home Intraocular Pressure Monitoring Device. J Glaucoma. 2011; 20 (2):74-79. Asrani S, Samuels B, Thakur M, Santiago C, Kuchibhatla M, Clinical Profiles of Primary Open Angle Glaucoma versus Normal Tension Glaucoma Patients: A Pilot Study. Current Eye Research. Informa Healthcare USA, Inc. 2011. 36 (5): 429-435. Crooks KR, Allingham RR, Qin X, Liu Y, Santiago-Turla C, Larocque-Abramson KR, Del Bono E, Challa P, Herndon L, Akafo S, Wiggs JL, Schmidt S, Hauser MA. Genome-wide linkage scan for primary open angle glaucoma: Influence of ancestry and age at diagnosis. PLoS ONE. 2011. 6(7): e21967. Liu Y, Gibson J, Wheeler J, Kwee LC, Santiago-Turla CM, Akafo SK, Lichter PR, Gaasterland DE, Moroi SE, Challa P, Herndon LW, Girkin CA, Budenz DL, Richards JE, Allingham RR, Hauser MA. GALC deletions increase the risk of primary open-angle glaucoma: the role of Mendelian variants in complex disease. PLoS ONE. 2011. 6(11): e27134. Crooks KR, Allingham RR, Qin X, Liu Y, Gibson JR, Santiago-Turla C, Larocque-Abramson KR, Del Bono E, Challa P, Herndon LW, Akafo S, Wiggs JL, Schmidt S, Hauser MA. Genome-wide Linkage Scan for Primary Open Angle Glaucoma: Influences of Ancestry and Age of Disease Onset. PLoS One. 2011;6 (7):e21967. Epub 2011 Jul 12. PMID:21765929, PMCID: PMC3134467. Liu Y, Gibson J, Wheeler J, Kwee LC, Santiago-Turla CM, Akafo SK, Lichter PR, Gaasterland DE, Moroi SE, Challa P, Herndon LW, Girkin CA, Budenz DL, Richards JE, Allingham RR, Hauser MA.GALC deletions increase the risk of primary open-angle glaucoma: the role of Mendelian variants in complex disease. PLoS One, 2011, 6(11) e27134. PMCID 3208571 Wallace D, Chau F, Santiago-Turla C, Hauser M, Challa P, Lee P, Herndon L and Allingham R. Osteogenesis imperfecta and primary open angle glaucoma: Genotypic analysis of a new phenotypic association. Molecular Vision. 29 August 2014; 1174-1180. Asrani S, Essaid L, Alder B, and Santiago-Turla C. Artifacts in Spectral-Domain Optical Coherence Tomography Measurements in Glaucoma. Jama Ophthalmo.2014; 132(4):396-402. Williams A, Allingham R, Beckwith H, Liu P, Santiago-Turla C, and Muir K. Patient and Family Attitudes about Eye Donation Registry for Research. Current Eye Research. 2013; 38 (9):945-951. Abstracts Hauser MA, Graham FL, Allingham RR, LaRocque-Abramson K, Santiago CM, DelBono E, Olson L, Haines JL, Wiggs JL, Pericak-Vance MA. Evidence for linkage but not association to the GABRB3 region of chromosome 15 in a subset of primary open angle glaucoma (POAG) families. ARVO, 2004: 4394/B855 Cohen CS, Challa P, Herndon LW.Pericak-Vance M, Abramson K,.Hauser M Wiggs JL, Allingham RR, Santiago, C. Prevalence of optineurin mutations in adults with primary open angle glaucoma in Ghana, West Africa. ARVO, 2004: 4627 Walter JW, Allingham RR, Flor JD, Abramson KR, Graham FL, Cohen CS, Santiago C, del Bono EA, Auguste J, Rogers K, Haines JL, Pericak-Vance MA, Wiggs JL, Hauser MA. Optineurin sequence variants do not contribute to high-tension primary open-angle glaucoma. Am J Hum Genet Vol. 73(5):506, 2003 Figueiredo Sena DR, Pasquale L, Allingham RR, Santiago-Turla C, Hauser M, DelBono EA, Pericak-Vance M, Haines JL, Wiggs JL. Distribution of p53 codon 72 polymorphism in primary open angle and low tension glaucoma. ARVO, 2003: 1119/B15 Abramson KR, Hauser MA, Allingham RR, Marks OA, Santiago C, Graham FL, del Bono EA, Pericak-Vance MA, Wiggs JL, Haines JL, R. Investigating Candidate Genes and Novel ESTs in Primary Open Angle Glaucoma. Am J Hum Genet Vol. 73(5): 542, 2003. Lee, P, Vann R, Allingham R, Herndon L, Challa, P, Santiago C. Optic Nerve Evaluation-Pilot study with Specialists and General Ophthalmologists. AGS, 2002 Lee, P, Santiago, C. Pilot Study of the Relationship of Literacy to Glaucoma Visual Loss. AGS, 2001. Santiago, C, Rivera M, Eclarinal J, Singson, M, Javate, R. Bamboo Charcoal as An Orbital Implant. American Academy of Plastic and Reconstructive Surgery, San Francisco, CA. 1996.
Skills
advertising, Anesthesiology, blood draws, blood pressure, business plan, calibration, Cardiology, Clinical Research, clinical trials, Data analysis, epidemiology, Financial Management, genetics, grants, laboratory tests, lamp, Neurology, Oncology, Ophthalmology, ophthalmologist, Personnel Management, Profit and Loss, program development, Psychiatry, regulatory documents, sample collection

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Resume Overview

School Attended
  • Duke University
  • Santo Tomas University Hospital
  • University of Santo Tomas
  • University of Santo Tomas
Job Titles Held:
  • Research Program Leader
  • Clinical Ophthalmic Assistant
Degrees
  • Masters
  • Residency Training Ophthalmology
  • Doctor of Medicine
  • Bachelor of Science

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