Job Description

Job Description

Job Description

General Description: Coordinates, supports and oversees the daily clinical trial activities and plays a critical role in the conduct of studies including the recruitment of study subjects. Collaborates with the Clinical Investigators and Clinical Research team to assist in the implementation of the research protocols as well as provide administrative and data collection support.

Core Duties and Responsibilities:

• Showcases in-depth knowledge of protocol requirements and Good Clinical Practices (GCP) as set forth by federal regulations
• Coordinates, supports, and facilitates on site, as well as in-home (remote) clinical studies in strict accordance with approved protocols
• Conducts research in accordance with Good Clinical Practice (GCP), Life Extension Clinical Research Standard Operating Procedures, Policies and Work Instructions as well as applicable local, state, and federal regulations.
• Monitors the protocol implementation and study progress, keeps team fully apprised of study progress with participation in team meetings
• Provides QA/QC activities for clinical studies ensuring protocol compliance and close subject monitoring making recommendations for quality improvement

• Supports the recruitment and retention activities, appointment scheduling, consenting, enrollment and follow-up, data collection and entry while adhering to the project timelines
• Plays an active role in successfully recruiting and enrolling participants for clinical studies
• Assists marketing with the promotion of the clinical research initiatives with evaluation and input to the initiatives

• Performs clinical tasks including but not limited to, managing study products, laboratory specimen storage/shipment, adverse event documentation and reporting in a timely manner
• Manages sample processing, packing, and shipping according to protocol, applicable standards and regulations
• Responsible for data management and integrity ensuring that the data from the source documents and laboratory reports are completed in a timely manner
• Provides support for the revision and consolidating of the current SOPs and Work Instructions to ensure adherence to current practice and regulations
• Provides support for the assessment and implementation of other CTMS systems and software for improvement in the efficiency, quality and reporting for the clinical trials
• Oversees and supports the preparation of source and data documentation whether as paper or eSource, adverse event reporting in a timely manner
• Maintains regulatory files to ensure completeness working with the Clinical Research Supervisor and LECR team

• Works with the Director and Clinical Research Supervisor in the design, coordinating and implementing all research projects
• Trains other staff in conducting and ensuring compliance with the protocol, federal and institutional requirements
• · Assists in the study product(s) dose preparation, ensures study product is received, inventoried, and stored securely; assists with dispensing study product(s) with proper documentation

• Reports any quality or subject safety concerns to the Director
• Supports the reporting of the progress of a clinical trial including the metrics for subject recruitment and tracking of the budget, expenses, and subject payments
• Responsible for the management of study materials and supplies- distribution, ordering, tracking, storage, reconciliation, and destruction
• Facilitates study close out activities and retains records/archives documents, as required
• Recognizes opportunities for own growth, takes responsibility to increase skill or knowledge level. Completes the required CE training and maintains certification(s), as required. Applies newly learned material to the position, as appropriate
• Flexibility to travel outside of the facility to recruit potential subjects (i.e., physician offices, health fairs, expos etc., as needed
• Regular onsite attendance is an essential function of this position (some flexibility for WFH after the first 90 days and dependent on types of studies being conducted)
• Other duties and responsibilities as assigned

Position Requirements:

• Bachelor’s degree in a related field
• Clinical Research Coordinator certification from Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA). Other certification from an accredited provider may be acceptable.
• Minimum of 3+ years’ experience working in clinical trials involving human subjects, database management, and experience with research regulatory compliance; Additional experience preferred
• Good analytical and problem-solving skills
• Comfortable working with subjects participating in person as well as remotely
• Demonstrated ability and understanding of clinical study subject recruitment, selection, and enrollment
• Schedule flexibility to accommodate changing business needs, travel as needed
• Working knowledge of Microsoft Office Suite
• Working knowledge of clinical research software programs including clinical trial management systems and electronic data capture
• Utilizes discretion in handling confidential information
• Detail-oriented and ability to analyze, organize and prioritize work in a fast-paced environment; ability to properly handle interruptions
• Ability to visualize objects closely required (e.g., reading thermometers)
• · Ability to do a variety of physical exertion with some and/or continuous standing or walking, for example in health fairs or giving presentations

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