Detail-oriented and driven clinical research professional able to coordinate operations, manage sites and draft detailed reports. Knowledgeable about action planning, database locking and standard operating procedures. Desiring a challenging new role as a Senior Clinical Research Associate. THERAPEUTIC AREAS
Oncology: Solid Tumors, Lymphoma, Leukemia, Melanoma and Breast Cancer
Infectious Disease: HPV and Flu
Neurology: Insomnia, Restless Leg Syndrome, Schizophrenia and Parkinson Disease
Rare Disease: Fabry Disease and Hunters Disease
Medical Device: Heart Valves (Hemodynamic Monitoring)
Over 5 years of clinical research experience.
Ability to travel nationwide 80% of the time.
Experience working in phases I-III clinical trials.
Excellent skills in basic communication applications (Word, Excel, Access, and PowerPoint).
Excellent knowledge of ICH and GCP.
Ability to work effectively both independently and on a team.
Excellent communication skills.
Experience performing all visit types.
SENIOR CLINICAL RESEARCH ASSOCIATE, 08/2018 to Current ECE Pharma – Houston, TX
Assists in the preparation of protocols, CRFs, regulatory binders, brochures, and study manuals.
Maintains compliant trial master files of all assigned PRA clinical studies and ensure each site is maintaining its regulatory binder as required.
Ensures each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.
Conducts qualification, onsite initiation, regulator interim, and close-out monitoring visits, as needed.
Performs training of investigators and study coordinators as needed.
Ensures timely completion of clinical reports, including monitoring visit reports.
Supports the Clinical team and participate in project management of trial and various improvement projects.
Recognizes potential obstacles and work to resolve them within set timelines.
Monitors emerging industry and regulatory trends to help integrate new requirements into department procedures (i.e.
Completes projects and tasks consistent with corporate objectives.
Attends relevant symposia, meetings, and conferences as needed.
Supports safety monitoring and processes as needed.
Participates in department systems and development initiatives including related trainings (i.e.
Electronic Data Capture, Clinical Trial Management System, etc.).
Performs other duties as assigned by Clinical Affairs management.
CLINICAL RESEARCH ASSOCIATE II, 01/2016 to 08/2018 ECE Pharma – Houston, TX
Independently performed on-site monitoring in accordance with client Standard Operating Procedures, ICH GCP guidelines and Regulations.
Participated in assessing study risks.
Communicated on behalf of the study manager with investigators and site staff.
Prepared study performance reports.
Assisted in preparation and independent execution of: Study training presentations for investigators and site staff.
Conducted site qualification, site initiation, routine monitoring and close out visits and reports.
Documented compilation for clinical study reports and document archive activities.
Performed data management activities including user acceptance testing, data entry, and data verification as needed.
Participated in clinical affairs meetings and completes independent activities to support departmental functions.
Completed all internal training programs in a timely manner, and demonstrates professional development via independent reading, networking and training.
CLINICAL RESEARCH ASSOCIATE I, 11/2014 to 01/2016 Active Site Pharmaceuticals – Houston, TX
Acted as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Developed strong site relationships and ensures continuity of site relationships through all phases of the trial.
Performed clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gained an in-depth understanding of the study protocol and related procedures.
Coordinated & managed various tasks in collaboration with other sponsor roles to allow site activation.
Participated & provided inputs on site selection and validation activities.
Conducted site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits.
Completed comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
Collected, reviewed, and monitored required regulatory documentation for study start-up, study maintenance and study close-out.
Communicated with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identified, assessed and resolved site performance, quality or compliance problems and escalates to Clinical Project Manager.
Manages and maintains information and documentation in Trial Master File, and various other systems as appropriate and per timelines.
Contributed to CRA team knowledge by acting as process expert, sharing best practices as appropriate/required.
Supported and/or lead audit/inspection activities as needed.
Performed remote and on-site monitoring & oversight activities using to ensure: 1) Data generated at site are complete, accurate and unbiased and 2) Subjects' right, safety and well-being are protected.