Clinical Research Medical

Highly motivated Research Project Specialist with over 7 years of progressive responsibilities and experience in pre-/clinical research activities, and operations support, with a strong background in study coordination, monitoring and quality assurance

Specialties: Pharmaceutical Research / Clinical Trials / Observational Study / Paramedical Examination / Drug Discovery/ In Vivo Models / Pharmacology / GPP, GCP and GLP compliance / ICH regulations

Therapeutic Areas: Vaccines / Immunology / Reproductive Health / Nephrology / General Surgery- Colorectal / Infectious Disease (Pulmonary: Tuberculosis, HCV) / CNS Disorders (Anxiety and Depression, Parkinson’s, Schizophrenia, Pain)

Technical skills: CITI, NIH and HIPAA certification, Specimen handling and processing, venipuncture, finger stick, vital sign monitoring

Computer skills: MS Office Suite, SPSS (beginner), Prism (Graph Pad), SharePoint, IDBS Software, Endnote

Data management systems: MIQS, NextGen, Cerner, Epic and Logician MR Systems, EDC, Inform, Medrio, eTMF: Veeva Vault, SPECTRUM

CLINICAL RESEARCH

Merck & Co., Inc., Rahway, NJ 06/2017 - Present

Center for Observational and Real-World Evidence (CORE)

Strategy and Operations

STUDY MANAGER (Contractor through Agile 1)

Provide project management/operational support to Lead CORE Scientists primarily in Epidemiology and Medical Policy and Quality Research (MPQR) groups, for study execution and conduct

Coordinate the planning and implementation of post marketing surveillance, safety, observational studies including primary data collection, chart review, and database studies.

Review requests for information/proposals, and statements of work as part of vendor selection process.

Lead sourcing activities through contract execution, and review confidentiality and consultant agreements.

Coordinate internal/external meetings, track timelines, and follow up on action items for final deliverables.

Assist in managing study level budget, including follow up of invoices, financial forecasting, accruals, and, communicating with stakeholders such as finance and procurement.

Liaise with ex-US vendors and cross functional teams including business development, pharmacovigilance not limited for adverse event reconciliation, regulatory and clinical teams, to communicate project milestones, status and project needs.

Participate in protocol and study report preparation, internal review procedures, and final approval, publication and archival process.

Participate in new initiative as a Champion to promote use of new eTMF system, Veeva Vault across CORE, representative for the MPQR group

Planned Parenthood of Northern, Central Southern New Jersey, Morristown, NJ 11/2015 – 06/2017

Medical Administration / Research

CLINICAL RESEARCH MANAGER (Consultant covering 10 Health Centers, NJ)

Managed the day-to-day operations of clinical research in the Affiliate by working in collaboration with VP of Research Development and health center staff to set up and complete studies, from SQV, SIV, Monitoring visits through close-out.

Provided program coordination in the area of clinical research, while ensuring compliance with all applicable regulatory requirements, study protocols, contractual specifications and company standards.

Educated and provided oversight to other staff members who are working within the scope of specific research objectives.

Conducted study procedures (recruit, enroll), resolve problems, address queries, and identify process improvements

Reviewed all study documents for accuracy and quality content.

Provided appropriate follow-up with protocol, budget, contract, enrollment progress, and resolution plans.

Served as a liaison for study sponsors with regard to data collection, health center monitoring and documentation.

DZS Clinical Services, Bound Brook, NJ 03/2015 – 11/2015

CLINICAL DATA CONSULTANT (Contract, New York, NY)

Provided critical, early stage extensive transcription of source documentation into clinical EDC system. Interacted daily with the client's nurses to perform data input functions, to suggest revision of data format and resolve discrepancies.

Collected comprehensive study data relating to patients with polycystic kidney disease by abstracting all trajectories of care including renal dialysis and transplant events and images, through medical chart review.

Prepared nurses’ summary notes.

Developed SOP and process for review of study communication with client's study team including IT group, and the Director of the Institute.

Provided timely and professional ongoing quality monitoring and management of data.

Saint Barnabas Medical Center, Livingston, NJ 11/2012 – 03/2015

Department of Surgery, Medical Student Research Institute

CLINICAL RESEARCH ADMINISTRATOR

Provided study lead and development for assigned registry, and investigator initiated and sponsor clinical studies within the Department (Phase III, IV).

Drafted, reviewed, executed and maintained project files during startup and recruitment including: feasibility reports, ethics committee/IRB approvals, informed consent forms, letters of agreement, confidentiality and budget agreement, protocols, serious adverse events (SAE) forms, electronic case report forms (eCRFs).

Audited source documents for completeness, and coordinating clinical sample processing and storage.

Maintained excellent communication and working relationships with IRB coordinators, Investigators, Legal, Internal stakeholders, and External service providers including Contract Research Organizations (CROs).

Oversaw the day-to-day operation and activities of the MSRI Research Program

Reported directly to the Director of Research, Chairman of Surgery to develop and coordinate Quality/Cost Research Initiatives, and to implement policies and procedure for efficient work flow.

Partnered with the Research Director to edit and submit clinical health outcomes research abstracts and manuscripts for oral, poster presentation and journal publication annually.

Supervised six salaried, three volunteer MD Research Fellows, conducted annual performance evaluations.

University of Medicine and Dentistry of NJ (now Rutgers), Newark, NJ 03/2011 – 11/2012

Department of Medicine, Global Tuberculosis Institute

CLINICAL RESEARCH ASSOCIATE

Implemented approved NIH Grant-funded investigator initiated Infectious Disease research study

Lead coordinator responsible for screening and obtaining informed consent, exceeding enrollment goal.

Abstracted and collected patient information through medical chart review and questionnaires.

Collected and processed study related pulmonary and venous specimens.

Reviewed study patient shadow and clinic charts for safety and quality assurance.

Constructed case narratives, based on analysis of patient medical records.

Maintained source documents, study charts and files, investigator logs, and supply inventory.

Supported the Nurse Manager and Investigator with IRB study protocol preparation and submissions, provided information and resolution for specific requests.

Participated in the evaluation, development and implementation of project database for medical data input.

Maintained relationships with key opinion leaders, and research laboratory site staff.

PRE-CLINICAL LABORATORY RESEARCH

Lundbeck Research USA, Inc., Paramus, NJ 03/2003 – 09/2010

Neuroscience Department, Behavioral Pharmacology Group

SENIOR RESEARCH ASSOCIATE

Instrumental in drug target and scientific-supporting projects: established and validated behavioral assays related to the CNS therapeutic areas of Anxiety, Depression, Parkinson’s disease and other related co morbidity indications. Planned, designed and performed in vivo pharmacology experiments in animal models, analyzed data and presented findings.

(2007-2009) Project Team Member

Neuropeptide Y (NPY: hypothalamic mediatory peptide) core team member, Neuropeptide FF (NPFF: pain modulating peptide) point contact person. Presented and communicated feedback of project related data to team leaders and members.

(2005-2010) Environmental Health and Safety (EH&S) Council Member

Liaison between Neuroscience and internal EH&S to ensure safety compliance of employees. Contributed to Lundbeck’s ISO 14001 and OHSAS 18001 Certification in 2009

PsychoGenics Inc., Valhalla, NY 05/2000 – 03/2003

Behavioral and Neurological Research Department

RESEARCH ASSOCIATE

Conducted and evaluated animal models for cognition, attention and schizophrenia for internal research group including characterizing phenotypes of transgenic mice, and training and mentoring new staff on departmental processes and procedures

CLINICAL RESEARCH PROJECTS

Study start-up, monitoring, execution (Phase I – III)

Planned Parenthood

Becton Dickinson. 2016-2017. Sample collection study evaluating performance of diagnostic assay in the detection of HPV

Roche Molecular Systems. 2017. Sample collection study evaluating performance of diagnostic assay in the detection of chlamydia and gonorrhea

Gynuity Health Projects. November 2016 – June 2017. A randomized placebo-controlled trial evaluating alternatives to treatment of continued pregnancy.

Title: Non-surgical alternatives to treatment of failed medical abortion: A randomized placebo-controlled trial

Columbia University. August 2016 – June 2017. A clinical trial research study to evaluate when providers can determine eligibility for termination of pregnancy without Ultrasound.

Title: Is transabdominal sonography comparable to transvaginal sonography for eligibility assessment prior to medication abortion?

Planned Parenthood Federation of America, Inc. (PPFA). August 2015 – March 2017. A clinical trial study evaluating the use of depo provera

Title: Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood

Saint Barnabas Medical Center

Excited States, LLC. 2015.

Title: Phase 3 Study of the Efficacy and Safety of Topical E-101 Solution to Prevent Incisional Infections Among Colorectal Surgery Patients (Triple IN Study-INhibition of INcisional INfections)

Cumberland Pharmaceuticals. 2015. A clinical trial study to assess the effectiveness of IV Ibuprofen

Title: Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics in Patients Undergoing Laparoscopic or Open Inguinal and/or Umbilical Hernia Repair? A Randomized, Double-Blind, Prospective Trial

EDUCATION

Certification in Clinical Epidemiology, expected completion date June 2020

Rutgers School of Public Health, Piscataway, NJ

ACRP-PM Certification, planned March 2019

PMP Preparatory Courses in progress

Association of Clinical Research Professionals, Alexandria, VA

M.S. in Biomedical Sciences, Concentration in Pharmacology, 2007

University of Medicine and Dentistry of NJ, Graduate School of Biomedical Science, Newark, NJ

Thesis: Potentiation of CRH-Enhanced Startle by Manipulation of Serotonin 1A Receptors

B.A. in Molecular Biology and Biochemistry, Minor in Psychology and Spanish, 2000

Rutgers University, New Brunswick, NJ

ARTICLES

Sparber LS, Lau CS, Vialet TS, Chamberlain RS. “Preoperative intravenous ibuprofen does not influence postoperative narcotic use in patients undergoing elective hernia repair: a randomized, double-blind, placebo controlled prospective trial." J Pain Res. 2017 Jul 5; 10: 1555-1560

Smith DG, Hegde LG, Wolinsky TD, Miller S, Papp M, Ping X, Edwards T, Gerald CP, Craig DA. “The effects of stressful stimuli and hypothalamic-pituitary-adrenal axis activation are reversed by the melanin-concentrating hormone 1 receptor antagonist SNAP 94847 in rodents.” Behavioral Brain Research, 2009. Feb 11; 197(2): p. 284-91.

R.T. Abner; T.S. Edwards; D. Brunner “Pharmacology of Temporal Cognition in Two Mouse Strains.” International Journal of Comparative Psychology, 2001.

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