Sajitha Nair
DeBary,FL
Summary
Aspiring Clinician and research professional with diverse experience conducting preclinical research in oncology, immunology, hematology alongside with Neuroscience and rare disease therapeutic areas. Extensive knowledge and professional experience in conducting and managing clinical trials (Phase 1-phase IV), well versed with research compliance, guidelines, and regulatory affairs. Additionally collaborated with KOls at clinical /healthcare settings, investigators at academic level and different healthcare settings, provided patient centered professional nursing care to a specified group of patients in infusion and procedural settings, caring for non-hospitalized patients (Oncology/Hematology) as well in the hospitalized settings.
Overview
15
15
years of professional experience
1
1
Certification
Work History
CRA II- Clinical Research Associate II
Premier Research
04.2023 - Current
- Developed and managed budgets for clinical trials according to study protocols.
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Contribute significantly to project planning, strategy, budgets, regulatory documentation, FDA pre-submission outlines, Informed consent form
- Interacted with sponsors, CROs, investigators, vendors and subcontractors as needed.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
- Tracked enrollment status across multiple sites to ensure target goals were met in a timely manner.
- Performed pre-study, site initiation visit, closeout and interim visits to check on study activities.
- · Provide mentorship to CRA and staff emphasis monitoring responsibilities and SOP understanding.
- Conducted all activities according to defined project-specific quality and performance standards.
CRA I- Clinical Research Associate I
Premier Research
04.2022 - 03.2023
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.
- Assessed incoming source documentation for accuracy and completeness against case report forms.
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
- Fronted site management and staff training (MD, PharmD, other scientific professionals, lab techs) for clinical trials across the USA aligning with study and site-specific monitoring plans.
- Conducted onsite and remote visits ensuring timely dispatch of confirmation letters, follow up letters and monitoring report with meticulous documentation for audits.
- Demonstrated expertise in assimilating new SOPs, IRB regulations, protocols, and medical terminology.
- Contributed significantly to the successful enrollment of subjects for the assigned study in the area of Pediatrics/Oncology
CRC-Clinical Research Co-ordinator
Accel Research Sites
DeLand , FL
01.2021 - 04.2022
- · Involved in all aspects of Phase 1 – Phase IV research for investigational drugs and medical devices such as for Immunotherapies, Vaccines, medications for Osteoarthritis, Pain medications, Hot flashes, Hypertension, Renal Impairment, Peripheral ischemic ulcers, Smoking cessation, devices for Arterial and Venous Stents.
- · Attended and participated in investigator meetings (IM), Site Initiation Visits (SIV), monitoring visits, and audits and performed all functions necessary for successful completion of all protocol required visits\procedures as delegated by the investigator, in accordance with study protocol.
- · Ensuredscientific integrity of data, protects rights, safety & well-being of patients followed by site compliance & regulatory requirements.
- · Conducted clinical trials followed by Standard Operating procedures (SOPs) & Good Clinical Parties (GCP).
- · Source data and lab data reconciliation and safety coding, collaborates with the clinical research team members to implement standard operating procedures (SOPs).
- Accurately completed source documents and case report forms in both paper and electronic format (EDC), verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria.
- Coordinated the recruitment of study participants through various channels, such as targeted advertisements and referrals from community partners.
- Reviewed consent forms for accuracy and completeness prior to participant enrollment in the study.
- Collaborated with other research teams to share resources, coordinate efforts, and ensure quality control across multiple projects.
- Participated in weekly team meetings to discuss progress on current projects and plan future initiatives.
Clinical Research Coordinator
Adventist Health System
Orlando , FL
09.2020 - 12.2020
- ·Conducted clinical studies in human subjects for phase III studies (COVID vaccines) according to FDA/GCP and ICH regulations & guidelines.
- ·Conducted in depth prescreening & screening visits for enrolling them in clinical studies, ensuring participant safety first.
- Performed a defined study activity such as ICF, screening & protocol procedures, maintaining source data, & entering data in the EDC as per the study requirements.
Infusion Registered Nurse-Contract -Onco/Hemat
Florida Cancer Research
Orange City , FL
05.2020 - 06.2020
- Assessed health status by completing a nursing assessment and notifies physician of abnormal findings.
- Administered medications and treatments safely with knowledge of their indications, utilizing nursing and medical center policies and procedures and providing patient centered care.
- ·Provided professional nursing care to a specified group of patients in infusion and procedural settings caring for non-hospitalized patients (Oncology/Hematology).
Registered Nurse -Step Down Intensive Care Unit
Adventist Health System
Orange City , FL
02.2018 - 03.2020
- Assessed, planned, implemented and evaluated nursing care for assigned patients.
- Collaborated with physicians, nurses, therapists, social workers and other healthcare professionals to develop individualized treatment plans for each patient.
- Participated in multidisciplinary team meetings to discuss patient care plans.
- Demonstrated knowledge of current trends in nursing practices by attending continuing education classes or seminars.
- Utilized critical thinking skills to assess clinical situations quickly and accurately.
- Maintained a safe environment for all patients by adhering to infection control policies and procedures.
- Coordinated discharge planning activities including arranging follow up appointments or referrals for additional services.
- Administered medications and treatments according to physician orders.
- Documented patient progress notes accurately and efficiently in the electronic medical record system.
Research Associate-Pediatric Oncology
University of South Florida College of Medicine
Tampa , FL
09.2011 - 10.2016
- ·Accomplished research budgets and expenses as well as led negotiations with vendors and administrative staff to ensure the best contract for the purchase of research reagents and equipment for all the stakeholders involved.
- Advanced scientific exchange through the communication of project outcomes to internal cross-functional stakeholders, sponsors, and the greater research community, which yielded pivotal insights that improved study design and supported data interpretation.
- Conducted biomedical research focused on Identifying and characterizing a novel protein, leukemia inducing factor (protein) from a fungal isolate responsible for altering the cell surface markers of acute lymphoblastic leukemia (ALL) in children.
- Actively participated in weekly meetings with the research team to discuss progress towards project goals.
- Assisted in writing grants proposals to secure funding for research projects.
- Utilized advanced techniques such as gene cloning, transfection studies, protein expression analysis and cell-based assays.
- Created presentations to explain research findings to colleagues and supervisors.
- Managed multiple projects simultaneously while meeting tight deadlines.
- Performed a variety of laboratory tests on samples including PCR, ELISA, DNA sequencing, cell culture, western blotting, qPCR assays and flow cytometry.
- Collaborated with other scientists to develop new methods for analyzing data.
- Reinforced the training and mentorship of approx..6-8 graduate and postdoctoral fellows through bi-weekly lab meetings and journal club presentations to discuss logistical and scientific topics related to lab function.
- Interpreted results of experiments and identified trends in data.
- Attended regional and national clinical/scientific conferences.
- Adapted general research methodologies to meet project-specific requirements.
Postdoctoral Fellow- Oncology/Tumor Biology /Drug
H.Lee Moffitt Cancer Centre & Research Institute
Tampa , FL
11.2008 - 07.2011
- Demonstrated exceptional relationship building skills through developing and maintaining cross-disciplinary collaborations with scientists and clinicians.
- ·Effectively engaged in the team’s scientific initiative, designed and conducted research, generated and analyzed scientific and pre-clinical data, leading to $6M in collaborative research funding.
- Investigated and identified the molecular mechanism involved in the genesis and progression of Non-small cell lung Cancer (NSCLC)therapeutics with the emphasis on Nicotinic acetylcholine receptor (nAChR) and Epidermal growth factor receptor (EGFR) receptor signaling.
- Attended regional and national clinical/scientific conferences.
- Enhanced the research team’s scientific knowledge and understanding through presentations at monthly meetings.
- Mentored and trained 6 junior research fellows.
- Authored 3 publications in peer-reviewed journals and contributed to the larger scientific community in the field of Drug discovery & Tumor biology.
Education
Bachelor of Science - Nursing
Utica College
Utica, NY05-2017
Ph.D. - Applied Biology
University of Mumbai
India12-2010
Master of Science - Biochemistry
University of Pune
India06-2002
Skills
- Site management
- Clinical trials
- Study monitoring, onsite visits, remote visits
- GCPs, ICH, IRB regulations, protocols
- Strategic thinking & Leadership skills
- Protocol review, Enrollment oversight
- Drug discovery, Oncology, Hematology, Immunology
- Cross functional Collaboration
- Records management, healthcare settings
- Patient management & care
- Investigational drugs and medical devices
- Clinical Trial Operations
- Written communication
- Social perceptiveness
- ICH/GCP/SOP guidelines
- HIPAA and FDA Regulations
- Key opinion leader(KOL)/PI collaboration
- Medical Affairs/Clinical research/Regulatory Guidelines
- Patient advocacy/Drug Safety
- Molecular, Microbiology & Cell biology technique, Animal models, cell culture
- Scientific Resource/Review
- Relationship building-Internal and External stakeholders
- Scientific/Medical expert
Certification
- MSL Career training program completion certification-MSLS
- Clinical Research training –from Clinical Research Fastrack
- Active RN certification
- Basic Life Support Certification (BLS)
- Advanced Cardiac Life Support (ACLS)
- NIDA (National Institute on Drug Abuse)
- GCP & CITI certification
- IATA certification
THERAPEUTIC AREA & PHASE STUDIES EXPERIENCE IN CLINICAL RESEARCH
· Pediatrics-Phase III- Probiotics-preventing NEC, Acute lymphoblastic leukemia
· Oncology- Phase I-Solid Tumor, Preclinical-NSCLS, ALL
· Neurology-Phases I- Alzheimer’s disease
· Nephrology-Phase I – Renal impairment
· Vaccines for COVID, Flu & Pneumonia-
Phase III-Pediatrics-COVID vaccine
Phase III-Adults Substance Abuse
Phase III- Smoking cessation
· Cardiovascular- PAD & DVT-Medical devices
· Musculoskeletal
Phase III-Osteoarthritis, pain relief
Phase II- Osteoarthritis
Phase III-Pediatrics/Adults-Soft tissue injury
PUBLICATIONS
- C. K. Tebbi, A. Badiga, E.Sahakian, A.I.Arora, S.Nair, J.J.Powers, A.N.Achille, M.V.Jaglal, S.Patel & F.Migone. Plasma of Acute Lymphoblastic Leukemia patients react to the culture of a Mycovirus containing Aspergillus Flavus. Journal of Pediatric Hematology/Oncology 2020 July, Vol 42, No.5
- S. Nair, D. Perumal & S. Chellappan. Nicotine induces the invasion of non- small cell lung carcinoma cells by modulating STMN3 and GSPT1 genes in an ID1- dependant manner. Molecular Cancer 2014 Jul ; 13:173)
- S. Nair, Nelson , & S. Nagaraj. CD4+ T cells suppress immune response to cancer: novel targets for antitumor effects. Expert review of Clinical Immunology, 8(5), 401-410, 2012. (Contributed equally)
- S. Pillai, W. Rizwani, X. Li, B. Rawal, S. Nair, M. Schell, G. Bepler, E. Haura, D. Coppola & S. Chellappan. ID1 is a common mediator of nAChR and EGFR signaling in non-small cell lung cancer. Molecular Cell Biology, 2011 Jul; 31(14): 3052-67
- S. Nair& P. Kumar. Molecular Characterization of a lipase producing Bacillus sp. strain NMSN-1d utilizing colloidal water dispersible polyurethane. World Journal of Microbiology & Biotechnology. Vol. 23, No. 10, October
Timeline
CRA II- Clinical Research Associate II
Premier Research
04.2023 - Current
CRA I- Clinical Research Associate I
Premier Research
04.2022 - 03.2023
CRC-Clinical Research Co-ordinator
Accel Research Sites
01.2021 - 04.2022
Clinical Research Coordinator
Adventist Health System
09.2020 - 12.2020
Infusion Registered Nurse-Contract -Onco/Hemat
Florida Cancer Research
05.2020 - 06.2020
Registered Nurse -Step Down Intensive Care Unit
Adventist Health System
02.2018 - 03.2020
Research Associate-Pediatric Oncology
University of South Florida College of Medicine
09.2011 - 10.2016
Postdoctoral Fellow- Oncology/Tumor Biology /Drug
H.Lee Moffitt Cancer Centre & Research Institute
11.2008 - 07.2011
Bachelor of Science - Nursing
Utica College
Ph.D. - Applied Biology
University of Mumbai
Master of Science - Biochemistry
University of Pune
- MSL Career training program completion certification-MSLS
- Clinical Research training –from Clinical Research Fastrack
- Active RN certification
- Basic Life Support Certification (BLS)
- Advanced Cardiac Life Support (ACLS)
- NIDA (National Institute on Drug Abuse)
- GCP & CITI certification
- IATA certification
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