Sr Clinical Trials Assistant resume example

Key Responsibilities

• Act as a central contact for the clinical team and site personnel for designated project communications, correspondence, and associated documentation during various study stages
• Manage the collection, review, and processing of essential documents from multiple research sites for submission to investigational product shipment authorization parties
• Coordinate key feasibility activities, including the processing of confidentiality disclosure agreements, site interest surveys, and other questionnaires
• Maintain various clinical systems that track site compliance and performance within project timelines
• Assemble and distribute study binders, CRF’s, and other supplies to participating clinical sites

Therapeutic Area Experience

• Hypercholesterolemia, Phases II, III
• Ulcerative Colitis, Phase III
• Non-Small Cell Lung Cancer, Phase III
• Multiple Early Development Trials, Phase 1

Key Responsibilities

• Recruited and coordinated the trial subjects covering informed consent, screening and inclusion of the subjects, adhering to safety and compliance issues
• Coordinated and managed the clinical trial through direct communication with the sponsor and other authorities, visit coordination, biological sampling, time management and product accountability.
• Collected and managed data utilizing source documents and case report forms, registered and managed AEs and SAEs, filed and archived various study documents, managed monitoring visits
• Close-out of the clinical trial, audit preparation, assisted in the final study report.

Therapeutic Area Experience

• Allergic Rhinitis, Phase II, III, IV
• Asthma, Phase II, III

• Served as an integral member of the primary patient care team, working along side doctors, nurses and other healthcare professionals to provide direct patient care in a post-surgical environment.
• Performed clinical procedures including, but not limited to the following: Obtaining Vitals ((temperature, heart rate, pulse ox, blood pressure and weight), Performing ECGs, Placement, Removal, and care of indwelling Catheters, Application of basic dressings, Drawing blood and obtaining any other specimens ordered by provider
• Provided outstanding patient care under the supervision of the Registered Nurse and other Health Care team members.

• Performed clerical duties related to transcription of physician orders, maintaining the patient record, direct admitting process and bed allocation, maintaining unit supplies, assessing patient charges, and other duties as assigned.
• Served as receptionist for visitors and patients.
• Coordinated all communications on unit.