Senior Clinical Research Coordinator
Job Locations: US-WI-Wauwatosa
ID: 2024-10717
Category: Research and Development
Position Type: Full Time
Overview
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life-saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.
Position Summary
Under the direction of the Principal Investigators (PIs) and CTRO Supervisor, is responsible for coordinating research trials from initiation to completion in compliance with regulations and requirements. Manages trial budgets and implements and oversees systems to manage the conduct of the clinical trials and the flow of information among stakeholders. May serve as a team lead or experienced coordinator mentor. May lead a disease function research area.
Responsibilities
- Subject Interaction: Obtains consent and enrolls study subjects. Communicates with study subjects, ensuring they receive applicable information. May include training and education regarding the study. Serves as a liaison between study subjects and Principal Investigator/research team to provide proactive communication. May collect samples from subjects as applicable/assigned.
- Stakeholder Interaction: Serves as a liaison with stakeholders including members of the research team, IRB (Institutional Review Board), study sponsors, hospitals/hospital staff, BCW staff, national data coordinating centers, and granting agencies. May include training and education regarding the study. Ensures receipt of applicable study data, reports, contracts, and information.
- Administrative Responsibilities: Coordinates the conduct of the clinical research project and protocols from initiation to completion in compliance with regulations and requirements. Designs, oversees, evaluates, and improves systems and processes to manage the conduct of the clinical trial and the flow of information among stakeholders. Prepares a variety of written materials that support the research study such as IRB documents, contracts/subcontracts, grants, manuscripts, educational and promotional materials, etc. Coordinates the collection and required reporting of applicable data to ensure smooth and accurate flow of information and when required, assists with data analysis. Prepares and manages clinical trial budgets, ensuring appropriate expenditures and resource utilization, while working with BCW grants administration regarding local and national budget issues. Designs, maintains and modifies databases, data entry/retrieval and record keeping systems. Supervises sample handling, storage, and shipment. Assists with study audits and performs the necessary steps to resolve any queries. Assists with and develops quality assurance procedures; evaluates study forms for completeness, accuracy and compliance with protocols. Manages study specific finances. Participates in budget design and review. May complete study specific invoicing. Assists in the training of new personnel.
- General Responsibilities: Maintains confidentiality of all subject-related records including written and verbal communications. Assists the Principal Investigator in day-to-day operations of the projects. Coordinates on-site and off-site meetings for project planning purposes and educational events as assigned. Leads process improvement activities. Participates in meetings, professional activities, etc. to keep current in skills and knowledge. May serve as the CTMS Administrator. May provide coverage for others and/or may instruct and direct the work of others.
- Performs other duties as assigned.
- Complies with all policies and standards.
Qualifications
Education:
- High School Diploma or equivalent required.
- Bachelor's Degree or equivalent work experience in related field required.
- Bachelor's Degree in science or another related field preferred.
Experience:
- 4-6 years of experience in a health care or research setting required.
- 4-6 years of clinical research experience required.
- 7-9 years of healthcare/research experience preferred.
- Experience with related clinical research preferred.
- Phlebotomy experience preferred.
Knowledge, Skills and Abilities:
- A leader in customer service and interpersonal skills required.
- Ability to be an effective liaison between study subjects and sponsors, investigators, health care workers, and collaborating professionals required.
- Advanced verbal and written communication skills including the ability to write, interpret and explain research studies and procedures required.
- Advanced ability to design, implement and manage projects that include planning, organization, prioritization, problem solving and performance of project tasks to ensure project completion within designated timeframes required.
- Very strong attention to detail and ability to evaluate and ensure accuracy of data related to laboratory results, subject health history, and data collection and reporting required.
- Strong proficiency with database functionality required.
- Ability to evaluate and extract data from medical records with ability to spot errors and trends and address promptly required.
- A leader in flexibility and dedication for handling a demanding, irregular schedule under pressure to meet deadlines required.
- Strong knowledge of regulations associated with human subject research required.
- Ability to work in an independent manner while providing mentorship to others required.
- Valid WI driver's license and access to a vehicle required.
- Independently takes initiative to enhance existing services and influence resulting action plans. Utilizes experience to act as a mentor to others on the team required.
- Leads a cohesive team approach by promoting the importance of working both within and across departments to achieve team and company goals required.
- Responsible for coaching or mentoring more junior team members but has no direct supervisory responsibility required.
- Proactively solves problems to affect change, makes informed decisions. Takes responsibility and is accountable required.
- As a skilled specialist, completes tasks in resourceful and effective ways. Tasks involve forward planning and anticipation of needs/issues required.
Licenses and Certifications:
- ACRP CCRC or SOCRA CCRP certification preferred.
Tools and Technology:
- Personal Computer (desk top, lap top, tablet) required.
- General office equipment (computer, printer, fax, copy machine) required.
- Microsoft Suite (Word, Excel, PowerPoint) required.
- EPIC medical record system required.
- Electronic Data Capture systems such as Redcap, Medidata, Inform, etc. required.
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