4 years experience as a Clinical Research Associate.
Therapeutic area includes:
CENTRAL NERVOUS SYSTEM:
Parkinson Disease Phase I
Multiple Sclerosis Phase III
Bipolar Disorder Phase III
Alzheimers. Phase II
Solid Tumor Phase I
Lung Cancer. Phase II
Ability to travel nationally 75%
Knowledge of GCP and FDA regulations
Ability to exercise good judgement and determine appropriate action.
Excellent time management skill and extremely organized
Excellent written and verbal communication skills
Ensures the safety of human trial subjects and the credibility of data collected in trials.
Excellent knowledge on project to effectively present information and respond to questions from project teams,, external vendors, and clinical sites.
EDC Systems :
CTMS and Report Writing:
Ensure timely resolution of EDC queries and site issues according to company''s SOP and Sponsor SOP.
Performs multiple Pre-Qualification Visits, Site Initiation Visits, Routine Monitoring Visits, and Close Out Visits.
Ensures the safety of Clinical trial subjects and the credibility ofor data collected by sites.
Ensures that local regulatory requirements and ICH/GCP guidelines are being implemented and also monitoring clinical trials to ensure that sponsor and investigator obligation's are being met.
Verifies SAE reporting according to trial specifications and ICH/GCP guidelines.
Performs query resolution and source document verification.
Reviews trip reports of entry level CRA.
Updates applicable tracking systems.
Maintains the site trial master file.
Tracks CRF status and ensure timely completion.
Ensure proper reconciliation of the Regulatory Binder with the Trial Master file.
Assess IP accountability, dispensation, and compliance at the investigative sites.
Prepares clinical monitoring tools for study team utilization.
Assures study related clinical activities are conducted in compliance with GCP/ICH guidelines, SOP's, and project requirements.
Build strong, long term relationship's with the investigators, study coordinators, and other site personnel based on professionalism, knowledge, and commitment to appropriate research parties.
Monitored and tracked patients enrollment and study progress.
Provides timely response to protocol/study related questions received from sites and or team leaders.
Develops and submits accurate trip reports according to Sponsor and CRO requirements.
Ensures that all required study documents and materials in regards to study execution are accurate, complete, maintained, and updated as required.
Supervises study related clinical activities at sites to ensure project specific requirements/metrics are achieved.
Manages identification and resolution of clinical trial data inquiries/data changes and communication to internal and external multi-function resources within project team.
Manages project activities to ensure the timely and quality preparation of project deliverables based on assigned scope-of-services such as EDC/IxRS maintenance study.
Coordinates with clients, vendors, and expert consultants to ensure all logistics, materials, and technologies necessary for successful training event's are in place.
Prepares and maintains in-study project plans, data management plans and study binders which will be executed in collaboration with Project Managers.
Trains and develops teammates as appropriate.
Oversees project QC activities to ensure compliance within the enterprise Total Quality Management System.
Independently facilitates virtual training sessions like LiveMeeting including attendee registration, training execution, and issue resolution.
Provides weekly status reports documenting project activities, planned steps and issues.
Tracks monthly and quarterly metrics( variable fee budgetary items) and provide to Project Manager for invoicing.
Manages communication's with clients. (e.g Sponsor, CRO) and site personnel regarding site/study details.
Produces data reports(e.g weekly, interim, final, etc) for submission to pharmaceutical clients.
Prepares study materials including system requirements, data transfer documentation, questionnaire, raterm experience surveys, response sheets, and other documents assume required.
Provides daily direction and communication to employees so that customer service calls are answered in a timely, efficient, and knowledgeable manner.
Writes and administers performance reviews for skill improvement.
Ensures employees have appropriate training and other resources to perform their jobs.
Responds to and resolves employee relations issues expressed by team members.
Establishes work procedures and processes that support the company and departmental standards.
Assists the manager with daily operation of the call center to include the development, analyses and implementation of staffing, training, telemarketing, scheduling, and reward/recognition programs.
Addresses disciplinary and/or performance problems according to company policy.
Prepares warnings and communicates effectively with employees on warnings and makes effective/appropriate decisions relative to corrective action as required.
Creates and maintains a high-quality work environment so team members are motivated to perform at their highest level.
Provides continual evaluation of processes and procedures. Responsible for suggesting methods to improve area operations, efficiency and service to both internal and external customers.
Provides statistical and performance feedback and coaching on a regular basis to each team member.
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