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Over 15 years as a multi-talented Clinical Research Professional managing Phase II-IV clinical trials in different therapeutic areas. Responsible for comprehensive project development and management. Experience also includes compliance according to ICH/GCPs and other regulatory agency guidelines. As well as dedicated experience in complying with study protocols, standard operating procedures. Practiced problem-solver with strong attention to detail. Proficient in handling patient information, laboratory samples, and compliance procedures for different clinical trials. Well-organized and hardworking with excellent communication and planning skills. Prepared to offer extensive experience in the field and take on a fast-paced position.
Vaccines, GI (Crohn's Disease, Ulcerative Colitis, IBS-D, IBS-C, GERD, Lactose Intolerance), Cardiovascular (Cholesterol, AFIB, HRVD), Neurology (Migraine, Parkinson's Disease), Respiratory (Asthma, COPD), | Other (Osteoarthritis, Rheumatoid Arthritis, Overactive Bladder, Insomnia), Endocrinology (Diabetes, Diabetic Neuropathy), Nephrology (CKD, Metabolic Acidosis, Dialysis). |
- Coordinated phases II-IV of clinical trials from study start up to study closure.
- Acted as liaison between the physician and sponsor.
- Conduct Quality Assurance and Quality Control, working under FDA, GCP, ICH Guidelines.
- Responsible for Subject recruitment and retention, IP administration for blinded and unblinded trial.
- Designed source documents for each clinical research study thereby optimizing the correct data is captured and study procedures are not missed.at specific subject visits.
- Update drug accountability logs and design other drug and data collection forms as necessary.
- Prepared for and participated in audits conducted by sponsors and other entities.
- Provide guidance to lower level personnel involved in planning, implementation and evaluation of clinical studies.
- Assists in training new personnel.
- Oversee adherence to study protocol, subject evaluations, treatment administration, and collection, processing, and shipping of biological specimens.
- Effectively met deadlines and consistently exceeded expectation for timely data collection and submission.
- Responsible for managing, coordinating, and ensuring overall integrity of research projects.
- Supervised clinical studies in accordance with institutional and ICH/GCP guidelines, SOP's.
- ICF Administration Conducted study visits in accordance with protocol requirements and assure accurate documentation.
- Responsible for maintaining source documents and subject accountability records.
- Maintained communications and solid working relationships with subjects and team members throughout entire trial.
- Complete eCRF's in timely manner, analyzed study data and prepare study reports for sponsors.
- Served as clinical liaison between sponsor and project teams to increase effective study coordination, directing research activities to ensure project milestones and corporate objectives are achieved.
- Maintained IRB compliance and track submissions.
- Supervised and assisted Clinical Research Coordinators.
- Conduct Quality Assurance and Quality Control, provided support and timely follow-up for quality assurance activities.
- Finalized IRB documentation, patient tracing sheets and protocol deviation's log.
- Verified subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.
- Assured compliance with ICH/GCP guidelines and sponsors SOP's.
- Maintained regulatory documentation according to Essential Regulatory guidelines and TMF plan.
- Clinical Trial Initiation, Attendance at Site Visits, subject recruitment, drug dispensation and accountability, data entry.
- Record keeping and documentation, scheduling appointments for subjects, monitors, and auditors.
- Assisted with Ambulatory Blood Pressure Monitor, vitals, laboratory procedures, and ECG's, pulmonary function test.
- Attended investigator and site staff meetings to discuss ICF process, protocol review, safety issues, AE reporting.
Betty Owen School - , New York
La Guardia Community College - New York,
New York, Long Island City High School - ,
• A 66-Week Extension to A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
• A Phase IIb Randomized, Placebo and Active Comparator (Tolterodine) Controlled, 2-Part Clinical Study of the Efficacy and Safety of MK-4618 in Patients with Overactive Bladder
• A Phase II Randomized, Placebo-controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adults with Autoimmune Disease
• A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Assess the Efficacy and Safety of Budesonide Foam (2MG/25ML BID for 2 Weeks, Followed by 2MG/25ML QD for 4 Weeks) Versus Placebo in Subjects with Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
• A Phase III Randomized, Double-blind, Placebo-controlled Multi-center Study of Subcutaneous Secukinumab in Pre-filled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long-Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNF Agents
• A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis
• DM199-2019-001, “A Multi-Center Open-label Investigation to Assess the Safety and Efficacy of Multiple Doses of DM199 in Patients with Chronic Kidney Disease (Stage II or III)”
- Fluent in English and Spanish both verbal and written, open and clear communication
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School Attended
- Betty Owen School
- La Guardia Community College
- New York, Long Island City High School
Job Titles Held:
- Certified Clinical Research Coordinator/ Data Entry/ QA
- Clinical Operations Supervisor/ Lead Clinical Research Coordinator/ QA & QC
- Clinical Operations Manager
- Clinical Research Coordinator/Regulatory Specialist
Degrees
- High School Diploma
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