Clinical Research Coordinator

Company: Apidel Technologies
Location: Newport Beach
Posted on: January 22, 2023

Job Description:

Duties: The candidate will help coordinate among Clinical Research Coordination team members conducting investigational clinical studies in accordance with Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures. Roles and Responsibilities Schedule and coordinate study meetings, materials and agendas; aligning objectives and coordinating activities Assemble data and complete routine analyses for a variety of reports. Enter data to records or logs and establish and maintain files. Become an expert user/administrator and manage system level tasks within the platform to support the Site Clinical Research Team. Coordinate and manage version control of clinical documents. Provide customer service to Sites; Respond to various inquiries from the Care Team and Clinical Research Team, physicians, telephone callers and visitors by providing information according to guidelines or directing alerts/messages to the appropriate person. May be required to act as liaison between investigational sites/vendors and department management. Assemble Clinical Research and Care Team training materials and manage workflow items to increase education where necessary in the process. Provide guidance and training to new administrative staff. Assist Clinical Lead with reference searches in support of protocol development and implementation. Identify and resolve administrative project issues. Participate in pre study visits, Site Initiation Visits, as appropriate. Support site initiation visit. Assist in study close visits. Assist in the creation and updating of standardized clinical trial tools and processes, SOPs associated with the Patient Recruitment methodology. Collect user feedback on ease of use, critical defects and bugs, enhancement requests and general sentiment related to product features and overall utility of the platform Experience, Education and Specialized Knowledge and Skills Must thrive working in a fast paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Essential Functions Clinical Care: Ensure that quality patient care is delivered to all patients on a 24 hour basis, and the unit is maintained in accordance with professional and regulatory standards and the philosophy and goals of the company. Perform other duties as assigned.

Skills: Skills or Other Qualifications Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures Experience with Oncology clinical studies and clinical trial protocol development and/or implementation Knowledge of ICH/GCP and regulatory environments including regulatory documentation review and approval Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical. Strong communication and interpersonal/team skills. Minimal travel required. Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project preferred. Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines. Strong initiative and a can do attitude, excellent organizational skills, proven effectiveness in a quick changing, fast paced environment, excellent people skills, and a proven record as a team player.

Education: Bachelor's degree required A minimum of 2 years experience in clinical operations or related field required, site CRC experience preferred (Oncology strongly preferred).

Languages:
English Read Write Speak

Keywords: Apidel Technologies, Newport Beach , Clinical Research Coordinator, Healthcare , Newport Beach, California