research coordinator Archives

2013 Study Coordinator for Hoffmann-LaRoche BC28034; A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared with Placebo in Patients with Type 2 Diabetes Mellitus (T2D) Who are Drug-Naïve to Anti-Hyperglycemic Therapy.· 2013 Study Coordinator for AstraZeneca D3250C00018; A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Cortocosteroid Plus Long-acting B2 Agonist in Patients with Uncontrolled Asthma (CALIMA).· 2013 Study Coordinator for MediVector T705aUS317; A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects with Uncomplicated Influenza.· 2013 Study Coordinator for Novo Nordisk NN9535-3623; Efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes.· 2013 Study Coordinator for Bristol-Myers Squibb CV181-206; A 24-Week International, Multi-Center, Randomized, Parallel-group, Double-blind Trial to Evaluate Metformin Extended Release Monotherapy in Adult Subjects with Type 2 Diabetes who have Inadequate Glycemic Control with Diet and Exercise.· 2013 Study Coordinator for Ferring Pharmaceuticals 000080-Echo 2; A Double-Blind, Randomised, Placebo-controlled, A Phase 3 Trial in Patients with Chronic Idiopathic Constipation to Demonstrate the Efficacy and safety of Elobixibat 5 mg and 10 mg for 12 Weeks Followed by a 4-week Withdrawal Period.· 2013 Study Coordinator for Shionogi 1326V9235; A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy.· 2013 Study Coordinator for Thrombosis EN3409-309; Prospective, multicentre, international Registry of male and female patients newly diagnosed with atrial fibrillation. · 2013 Study Coordinator for Bristol-Myers Squibb Astra Zeneca CV181-169; A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3 Trial to Evaluated the Safety and Efficacy of Add-On Therapy with Saxagliptin and Dapagliflozin added to Metformin compared to Add-On Therapy with Saxagliptin in combination with Metformin or Dapagliflozin in combination with Metformin in Subjects with Type 2 diabetes who have Inadequate Glycemic Control on Metformin Alone.· 2013 Study Coordinator for Biota BTA51-350-201; A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm study to Investigate the Efficacy and Safety of Inhaled LaninamivirOctanoateTwinCaps Dry Powder Inhaler in Adults with Symptomatic Influenza A or B Infection.· 2013 Study Coordinator Carmelina 1218.22 A multicenter, international, randomized, parallel group, double-blind, placebo-controlled cardiovascular safety & renal microvascular outcome study with linagliptin, 5 mg once daily in patients with type 2 diabetes mellitus at high vascular risk.· 2014 Study Coordinator Astra Zeneca D589GC00003 A phase 3, 12-week, double-blind, randomized, parallel-group, multicenter study investigator the efficacy and safety of symbicortpMDI 80/2.25 ug, 2 actuations twice daily and symbicortpMDI 80/4.5 ug, 2 actuations twice daily, compared with budesonide pMDI 80 ug, 2 actuations twice daily in children ages 6 to < 12 years with asthma· 2014 Study Coordinator Janssen&Janssen 28431754DIA4003 A randomized, multicenter, double-blind, parallel, placebo-controlled study of effects of canagliflozin on renal endpoints in adult subjects with type 2 diabetes · Performed lab draws on all patients

Principle administrative liaison;
Recruit and coordinate research subjects;
Develop study protocol and procedures;
Organize and analyze data collected;

Resolve problems concerning transportation, logistics systems, imports or exports related to investigational products.
Collected, reviewed and maintained regulatory docuements and performed IEC submissions.
Maintain metrics, reports, process documentation, patient service logs, or training or safety records.
Asisted in final closure of study.
Performed source docuement verification, retrieves case report form and perform query resolution in a timely manner and overseas drug accountability and safety at Investigator sites.

Utilized time management skills to balance coordinating five simultaneously active studies in a detail-oriented, organized, and efficient manner.
Developed study procedure protocols and analysis plans in accordance with investigators and statistical analyst to ensure collection, processing, and organization of high quality data.
Coordinated and collaborated with different institutes, clinical professionals, investigators, and research team to ensure the efficiency and accuracy of completing study procedures with high attention to details.
Develop an on-boarding program and train new research staff.

Proofing for Data Entry
Preparing patient/participant documents for study visits and assisting with submission of documents to IRB and study sponsors, along with collection of study required specimens.
Conducting informal consents to subjects going on trial
Coordinating the activities of assigned research protocols, generally non-interventional in nature.
Requesting of study related tissue while maintaining tracking board for Thoracic department.

Check to see if patient qualified for a research study
Enroll children into a study
Document for study
Phlebotomy and prepare specimen for shipment
Schedule Follow up Appointments

Conduct, establish and document research on a range of business and technology topics like digital identity, Block-chain and distributed technologies
Identify project goals, research methods, variables, and other test parameters
Collect data, perform analysis and offer recommendations on evaluating the project for the management and relevant teams
Implement security software protocols to keep research projects confidential
Hire and coordinate a team of freelance researchers to do niche research and accommodate peaks in the volume of research

conduct mystery shop calls and visit store islandwide
evaluate reports
Qualitative and quantitative research,
Data analysis and report writing

Prepare tables, graphs, fact sheets, and written reports summarising research results.
Interview participants to collect research information.
Research design and survey programming.
Writing successful proposals and tender submissions.

Map and organise the progress of a research project, emphasising responsiveness and strategic problem solving
Encourage, schedule and undertake stakeholder engagement
Conduct and combine qualitative and quantitative research methods to deliver collated data to the client
Training research staff on protocol and ethical guidelines

Developing research proposals
Data collection tools,
Obtain IRB approvals
Formulate Standard Operating Procedures
Ensure appropriate community entry for all research studies
Budget tracking
Procurement of project supplies

Preformed pre-review of research protocols for submission to Institutional Review Board to ensure compliance with federal regulations governing human participants in research
Developed online tracking system for protocol reviews to meet department metrics
Prepared and organized research protocols for submission to reviewing committees
Responsible for maintaining minutes of review committees and coordinate follow up requests to researchers regarding approval process