JANETTE ELLIS
Oceanside,CA
Summary
Reliable and trustworthy Clinical Research Coordinator
Detail-oriented Research Coordinator familiar with documentation, reporting and compliance guidelines. Specializing in study design and protocol development. Prepared to leverage expertise and 16 years of experience to make an immediate positive impact on research management at Cadena Care Institute
Overview
20
20
years of professional experience
Work History
Research Coordinator/Manager
Cadena Care Institute
Poway, CA
01.2022 - 01.2024
- Coordinated research activities to ensure compliance with institutional protocols and regulatory requirements.
- Developed and maintained project timelines, ensuring timely completion of deliverables.
- Facilitated communication between research teams, stakeholders, and funding agencies to streamline processes.
- Oversaw data collection procedures, ensuring accuracy and integrity throughout projects.
- Trained new staff on research protocols and best practices to enhance team performance.
- Implemented process improvements that increased operational efficiency in research workflows.
- Managed budget allocations for multiple projects, optimizing resource utilization across initiatives.
- Analyzed research findings to support strategic decisions and enhance project outcomes.
- Prepared documents, reports, and presentations detailing results and conclusions.
- Reviewed literature extensively to stay informed about industry trends and advancements in related fields of study.
- Managed multiple projects simultaneously, ensuring timely completion and high-quality results.
- Increased research efficiency by streamlining data collection and management processes.
- Organized regular training sessions for team members on various topics such as statistical software usage or research ethics protocols.
- Improved participant recruitment strategies, leading to a higher number of qualified candidates for studies.
- Maintained strict adherence to ethical guidelines in all aspects of research coordination, ensuring study integrity and compliance with regulations.
- Presented findings at conferences or workshops, showcasing accomplishments while also promoting future collaborations within the field.
- Gathered, processed, and shipped lab specimens.
- Mentored junior researchers, providing guidance on best practices and professional development opportunities.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Followed informed consent processes and maintained records.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Mentored staff on best practices, driving team development and skill enhancement.
- Accomplished multiple tasks within established timeframes.
- Maintained professional, organized, and safe environment for employees and patrons.
- Maximized performance by monitoring daily activities and mentoring team members.
- Cross-trained existing employees to maximize team agility and performance.
- Developed and maintained relationships with customers and suppliers through account development.
- Improved safety procedures to create safe working conditions for workers.
Clinical Research Coordinator
ACRC STUDIES
Poway, CA
01.2019 - 03.2021
-Responsibilities - Coordinate ongoing and new clinical trials activities. I provide guidance on all administration: Presite, SIV with sponsor, monitors. Adhere to compliance, financial, and other related aspects of clinical trials. Trained new employees, worked closely with PI regarding scheduling, andimportant issues inlabs regarding abnormal labs. Stay on top of queries, monitors, andscheduling of monitors; be available always for monitors, making source documents, communicating with patients, follow up, updating all training, keep all Investigational logs up to date, adding data within the sponsor timeline, SAE events, always making PI aware of important issues.
- Coordinated with cross-functional teams to align project goals and share valuable insights.
- Established strong relationships with external partners to facilitate collaborative research efforts.
- Designed innovative solutions for overcoming challenges encountered during the course of projects, resulting in successful completion despite obstacles.
- Coordinated protocol development, equipment preparation, and materials purchasing for planned studies.
- Complied with research protocols by providing ongoing quality control audits.
- Reviewed referral information and kept track of intakes from various referral sources.
- Monitored project progress closely, proactively addressing any issues that arose to ensure smooth operations.
- Collected, evaluated, and modeled collected data.
- Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
- Oversaw inventory management, optimizing stock levels, and reducing waste.
- Recruited, interviewed, and hired employees and implemented a mentoring program to promote positive feedback and engagement
- Improved participant recruitment strategies, leading to a higher number of qualified candidates for studies.
Clinical Research Coordinator
Integrated Research Center, Inc.
San Diego, CA
01.2017 - 01.2018
- Responsibilities- Implement coordinate daily clinical trial activity provides guidance on administration; Compliance,financial and other related aspects of clinical studies. Train and mentor new study personnel, Skilled in medical laboratory and clinical procedures, tactful communicator, adept at prioritizing managing tasks and meeting all deadlines. Support and assist the Principal Investigator in conducting and managing clinical trials.
Lead Clinical Research Coordinator
ENCOMPASS CLINICAL RESEARCH N.C.
Encinitas, CA
01.2007 - 01.2015
- Supported and assisted the Principal Investigator in designing; conducting and managing clinical trials. Assured prompt, accurate data flow to Pharmaceutical Sponsors; Participated in preparation and management of research budgets and monetary disbursements; screen subjects for eligibility using protocol specific inclusion and exclusion criteria in clinical trials; Informed patients and caregivers about study aspects and outcomes to be expected. Coded; evaluate and interpret collected study data; reviewed protocol; monitored study activities to ensure compliance with protocol and with all relevant local, federal, state regulatory and institutional policies. Maintained required records of study activity, including case report forms; drug dispensation/return records; drug storage; laboratory supplies; data and regulatory forms. Communicated with laboratories and investigators regarding laboratory findings. Attended investigator meetings as required or requested by the PI.
- Implemented recruitment strategies in accordance with Institutional Review Board (IRB) requirements and approvals.
- Coordinated; facilitated and monitored visits.
- Provided Incident Management; promptly informing the Principal Investigator on any unanticipated cases.
- Performed various laboratory procedures: Phlebotomy; ECGs; 24-hour Holter monitoring; masterscope spirometry; daily temperature logs and vital signs.
Histology Assistant
TRI-CITY MEDICAL CENTER
Oceanside, CA
01.2004 - 01.2007
- Organized; accessioning and processed surgical specimens; provided pathological examination; performed MOHS frozen process and cut tissue.
Education
Medical Assistant certification - Medical Assisting
Mesa Community College
San Diego, CA01-1991
Certification - Advanced Didactic Phlebotomy Training
Vista Adult School
Vista, CA01-2000
Certification - Phlebotomy
Kaiser Permanente
San Diego, CA01-1979
Some College (No Degree) - Project Management
Coursera UCI Extension Online
Online Skills
- Research Protocol
- Patients Communication Management
- Research Investigation
- Vital Signs
- Clinical Trial Management Systems
- Inform consent process
- Cardiopulmonary Resuscitation (CPR)
- 24-hour Holter Monitoring
- Venipuncture / Blood Draw
- EKGs
- Spirometry and Phlebotomy
- Management of research budgets and monetary disbursements
- Data Capture
- Electronic Data Entry
- Statistical Software
- Web-based source documentation
- MS Office suite
- Supported and assisted Principal Investigator designing, conducting & Managing clinical trial
- Data collection
- Equipment monitoring
- Ethics compliance
- Equipment operation
- Participant screening
- Study protocols
- Research sops understanding
- Informed consent
- Patient recruitment
- Meeting coordination
- Schedule coordination
- Records maintenance
- Good clinical practices
- Specimen handling
- Documentation management
- Specimen collections
- Site management
- Phlebotomy
- Medication dispensing
- Dispensing oversight
- Trial oversight
- Study monitoring
- Laboratory results management
- Adverse event tracking
- Case report management
- Protocol review
- Teamwork and collaboration
- Problem-solving
- Time management
- Attention to detail
- Multitasking
- Problem-solving abilities
- Reliability
- Excellent communication
- Patient education
- Safety reporting
- Task prioritization
- Medical terminology
- Professionalism
- Record keeping
Clinical Trials
- Glaxo- Smith -Kline GSK 3196165 Moderate to Severe Rheumatoid Arthritis. 52 week Phase III, multicenter, randomized, double -blind, efficacy and safety comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who has inadequate response to methotrexate. 2020 8 S 4 R
- Horizon HZNP-KRY-202 Phase III Gout study, Randomized, double -blind, placebo controlled, multicenter, efficacy and safety. Study of methotrexate to increase response rates in patients with uncontrolled gout. Receiving Krystexxa (pegloticase)Mirror randomized controlled trial 2020-2021 4R
- Eli Lilly 14V-MC-JAIM SLE Ext. open label Baricitinib rollover 3 rolled over. 2021
- Eli Lilly 14V-MC-JAHZ SLE Phase III, A Randomized, double-blind, placebo controlled, parallel-group Baricitinib in patients with Systemic Lupus Erythematosus. 2020 10 S, 8 R
- Dyve Bioscience DVY-703 Pilot, Randomized, Double Blind, Placebo Controlled study of the efficacy and safety of a topical pain relieving and alkalinizing treatment for reducing pain associated with an acute gout flare.2019 10 R
- Allergan 3151-201 Phase II 54 week treatment, multicenter, Randomized, double blind.double Dummy Placebo and active controlled, Parallel-Group. Efficacy and safety of Brazikumab in participants with moderately to severe active Ulcerative Colitis.2018 1 R
- Selecta SEL-212-202 Phase II Gout to Compare the efficacy of SEL-212 to Krystexxa Infusion 2018 20 S, 4 R
- Centrexion 4975i-OA-304 Phase III 20 S, 5R 2019
- Novartis CQAW039A2317 Phase III - A 12 week, multicenter, randomized, double blind, placebo-controlled study assessed the efficacy and safety of QAW039/Fevipiprant when added to standard-of-care asthma therapy in patients with uncontrolled asthma. 01/2018 Open enrollment.
- Novartis QVM149B2301 Phase III - A multicenter, randomized, 52 week treatment, double-blind, triple-dummy, parallel-group study to assess the efficacy and safety of QMF149 compared with mometasone furoate in patients with asthma 02/2018 Open Enrollment.
- Novartis CQAW039A2315 Phase III - A 2 treatment period, randomized, placebo-controlled, multicenter, parallel -group study to assess the safety of QAW039 when added to existing asthma therapy in GINA Steps 3, 4 and 5 patients with uncontrolled asthma. 03/2018 Open Enrollment (rollover extension 2317)
- Pearl PT0100OS Phase III randomized, double-blind, multicenter, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbation over a 52 week treatment period in subjects with moderate to very severe COPD. 03/2018 Open Enrollment (patients who participated in the PT009003 are not eligible to enroll)
- Pearl PT010012 Phase II/III - a randomized, double-blind, parallel-group, multicenter 24 week study comparing the efficacy and safety of three doses of PT001 to placebo and open label Spiriva Respimat In subjects with persistent asthma. 03/2018 Open Enrollment.
- Abbvie M16-100 Phase IV - A testosterone replacement therapy for the assessment of long term vascular events and efficacy response in hypogonadal men (TRAVERSE) study. Randomized, double-blind, Placebo-controlled, multicenter study of topical testosterone replacement therapy in symptomatic hypogonadal men with increased risk for cardiovascular disease. Pre SIV completed 01/2018
- Pearl PT009003 Phase III - A randomized, double-blind, parallel-group, multicenter study to assess the efficacy and safety of PT009 compared to PT005 in subjects with moderate to very severe COPD. End of Trial 09/07/2017 - 03/2018 R- 9
- Shionogi 1602T0832 Phase III multicenter, randomized, double-blind study of a single dose of S-033188 compared with placebo or Oseltamivir 75 mg twice daily for 5 days in patients with influenza at high risk of influenza complications. 11/2017-03/30/18 Closed Enrollment. R-2
- Hypertension: Eli Lilly: A randomized, placebo-controlled, double-blind, parallel-group, Phase 2 Study to evaluate the safety and efficacy of LY2623091 in patients with primary hypertension 1/2014 – 1/2015 G: 6 S: 13 R: 7 C: 7
- Pfizer PCSK9i Study: Phase III double-blind, randomized, placebo controlled parallel group study to assess efficacy, safety and tolerability of PF-04950615 in subjects with primary hyperlipidemia or mixed dyslipidemia at risk of cardiovascular events. 12/2013 – 2/2015 G: open enrollment S: 20 R: 14 C:
- Pfizer PCSK9i Study- Phase III double-blind, randomized, placebo-controlled parallel group study to assess efficacy Safety and tolerability of PF-04950615 in reducing the occurrence of major cardiovascular events in high risks in subjects. 12/2013 – G: open enrollment S: 2 R: C:
- GSK COPD: Phase III, 52 week, randomized, double-blind, 3 arm parallel group study, comparing the efficacy, safety, safety and tolerability of a fixed dose combination FF/UMEC/VI with the fixed dose dual combinations of FF/VI and UMEC/VI all administered once-daily in the morning via dry powder inhaler in subjects with COPD. Enrollment 8/2014 - G: 8 S: 7 R: 4 C:
- BIPI: Phase IIIb A randomized double-blind parallel- group 12 week study for patients with COPD: enrollment 10/2012 – 04/2013 G: 10 S: 20 R: 16 C:
- Amylin Pharmaceuticals Type II Diabetes Mellitus Phase III: A randomized, long term open-label 3 arm multicenter Study for subjects on stable dose of diabetic medication regime with type II diabetes mellitus. Enrollment : 2/2013 G: not to exceed 20 S: 7 R: 3 C: 3
- Merck Phase III Type II Diabetes Study: A randomized, double-blind placebo controlled multicenter study to assess Cardiovascular outcome following treatment in subjects with Type II diabetes mellitus. Enrollment: 1/2013 G: not to exceed 20 S: 7 R: 5 C:
- Hypertriglyceridemia: Novartis Phase II: A multicenter randomized active comparator placebo controlled study for patients with severe hypertriglyceridemia, enrollment: 7/2012 – 4/2013 G: 2 S: 4 R: 3 C: 1 ET: 2 due to adverse event.
- Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II study in subjects with severe Hypertriglyceridemia. Enrollment: 10/2010 – 06/2011 - 03/2010 G:5 S: 23 R: 7 C: 7
- BIPI GLORIA-AF Global Registry on Long Term Oral Antithrombotic Treatment in patients with Atrial Fibrillation Phase IV 06/2012 – Open enrollment to date (06/01/2015) 18 subjects enrolled. Total 14
- Type II Diabetes: J & J (Jansen) 28431754DIA-3012 (add on site) Phase III Randomized, Double-Blind, Placebo Controlled, 3 arm Parallel-Group, 26 weeks Multicenter Study with a 26-week Extension to evaluate the efficacy, Safety and Tolerability of JNJ-28431754 (Canagliflozin) Compared with Placebo in the Treatment of subjects with Type 2 Diabetes Mellitus with inadequate Glycemic Control of Metformin and Pioglitazone Therapy: Enrollment as an ad-on site: 02/03/2011 to 05/05/2011 G: 4 S: 6 R: 2 C: 2
- Type II Diabetes: J & J 28431754DIA3009 Phase III A Randomized, Double Blind, 3 arm Parallel-Group, 2-year (104 week), Multicenter study to evaluate the efficacy, safety and tolerability of JNJ-28431754 100 mg and 300 mg compared with Glimepiride (Amaryl) in the treatment of subjects with Type II Diabetes Mellitus not optimally controlled on Metformin Monotherapy. Enrollment: 10/2009 – 12/2010 G: 8 S: 13 R: 7 C: 6 ET: 1
- IBS-Diarrhea: Salix Pharmaceuticals Phase III study for subjects with irritable bowel syndrome with diarrhea (IBS) Enrollment: 08/2012 G: up to 10 S: 12 R: 3 C: Total 5
- Chronic Constipation: Forest A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial for 12 weeks in patients with Chronic Constipation. Enrollment 09/2008 – 03/2009 G: 12 S: 4 R: 5 C: 4
- Type II Diabetes: Kowa Phase II multicenter, Randomized, Parallel-Group, Double-Blind, Placebo and Active Controlled Phase II Dose Finding Study in Patients Not Well- Controlled current diabetic therapy. Enrollment: 07/2010 – 01/2011 G: 8 S: 6 R: 3 C: 3
- COPD: BIPI Phase III A 24-week Study Controlled in subjects with COPD. Enrollment: 10/2009 – 07/2010 G: 2 S:11 R: 6 C: 6
- COPD: Forest Research A dose ranging study in patients with COPD. This study will be conducted as a multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose ranging 12 week study. Add on site. Enrollment: 10/2008 – 01/2009 G: 10 S: 11 R: 5 C: 5
- COPD: BIPI Phase 3b A Randomized, Active Controlled, Double-Blind, Double Dummy, Parallel-Group Design multicenter Trial for patients with moderate to severe COPD. 07/2010 – 10/2010 G: 10 S: 30 R: 15 C: 15
- COPD: GSK Phase III A 24 week Study Placebo Controlled in subject with COPD. Enrollment: 10/2009 – 07/2010 G: 10 S: 27 R: 10 C: 8
- IBS with Constipation: Forest A Phase 3, Randomized, Double-Blind, Placebo controlled, Parallel Group Trial inPatients with IBS with Constipation. Enrollment 07/2009 – 02/2010 G: 8 S: 12 R: 5 C: 3
- Diabetes Type II Forest: Phase III A phase 3, Randomized, Double-Blind, Placebo-Controlled, multicenter study in patients with Type II Diabetes. Enrollment: 07/2009 – 09/2010 (terminated 06/2010) G: 8 S: 10 R: 7 C: 1 Forest terminated the study.
- Diabetes Type II Forest: Phase 3 phase 3, Randomized, Double-Blind, Placebo-Controlled, multicenter study in patients with Type II Diabetes Mellitus. Enrollment 07/2009 terminated 06/2010 G: 8 S: 10 R: 2 (2 subjects in run-in when study was terminated).
- Hypertriglyceridemia: Elevated Triglyceride Levels in patients on Statin, Amarin: A Phase III, multicenter, Placebo-Controlled, Randomized, Double-Blind, 12 week study to evaluate Fasting Triglyceride Levels (=> 200 mg/dl and 40 mg/dl and
- Hypercholesterolemia: Sanofi Aventis A Randomized, Placebo- Controlled, “factorial” design, 12 month study in patients with primary hypercholesterolemia. Enrollment 08/2008 – 01/2009 G: up to 20 S: 43 R: 23 Early termed 05/2009
- Drug Naïve Type II Diabetes BMS: Phase III : A multicenter, Randomized, Double-Blind, Active Controlled, Parallel-Group, Phase 3 Trial in subjects with Type 2 Diabetes who have inadequate Glycemic Control. Enrollment 05/2008 – 03/2009 G:3 S: 5 R: 4 C: 4
Timeline
Research Coordinator/Manager
Cadena Care Institute
01.2022 - 01.2024
Clinical Research Coordinator
ACRC STUDIES
01.2019 - 03.2021
Clinical Research Coordinator
Integrated Research Center, Inc.
01.2017 - 01.2018
Lead Clinical Research Coordinator
ENCOMPASS CLINICAL RESEARCH N.C.
01.2007 - 01.2015
Histology Assistant
TRI-CITY MEDICAL CENTER
01.2004 - 01.2007
Medical Assistant certification - Medical Assisting
Mesa Community College
Certification - Advanced Didactic Phlebotomy Training
Vista Adult School
Certification - Phlebotomy
Kaiser Permanente
Some College (No Degree) - Project Management
Coursera UCI Extension Online