Research Assistant II - Safety

Research Assistant II – Safety Management We are looking for a Research Assistant II to join our team! Are you well organized and adaptable to unexpected changes? Do you have good computer skills and a knack for details? If the answer is yes, keep reading! In this position you will: - Support administrative aspects of safety management such as: - Data entry and verification - Manage and respond to project related emails - Accurate and timely delivery of information to other project team members - Generate and distribute reports to relevant project team members - Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submission of documents to the Trial Master File. - Correspond with investigational sites, CPC staff and sponsors to rectify data queries and collect outstanding documentation. - Assist in tracking receipt, entry, upload, reviews and feedback to investigational sites of endpoint testing. - Assist with the printing, collation and distribution of study materials to project team members, sponsors and sites. - Assist with query management. - Assist with User Acceptance Testing (UAT) and manage user access requests (including user reconciliation). - Work closely with other team members to ensure timely completion of deliverables and resolution of issues. - Participate in project, program, functional area and general CPC meetings as required. - Adhere to CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations. - Serve as a study coordinator for select projects as needed. - Additional activities as required. - Based on business needs, may provide assistance to the following functional areas: - Research Operations - Community Health - Endpoint and Specialty Services - Site Operations - Data Management - Quality Control - Trial Master File Here’s what you will need to bring to the table: - GED or HS Diploma required. Nursing or bachelor’s degree preferred. - Minimum of 1 years of experience working in a clinical research (or similar) setting. Higher degree may be considered in lieu of experience. - Medical Assistant/C.N.A background a plus! - Demonstrated ability to complete core tasks with minimal direction, while reliably escalating for guidance on less routine assignments. - Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. - Good understanding of the drug development process. - Proficiency in MS Office, particularly spreadsheet databases and word-processing. - Excellent communication and organizational skills. - Great attention to detail - Ability to work with others in a manner that promotes group effort and achievement. - Ability to shift priorities quickly while ensuring accuracy and timely completion of tasks. - Ability to manage conflicts and resolve problems effectively. - Ability to discern priorities and obtain direction to accomplish day-to-day tasks. Note: Viable applicants will be required to pass a background and education verification check. Targeted Compensation: $20.75/hr - $24.40/hr About CPC: CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials. CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/ CPC offers: - Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.) - Matching 401(k) plan (dollar for dollar up to…