Clinical Research Coordinator - Germantown, WI - Part-Time

Clinical Research Coordinator - Germantown, WI - Part-Time Site Bridge Description

Founded in 2021, Site Bridge Research is a community-focused integrated research organization, building a national network of community practices to deliver world-class industry-sponsored clinical research on time and on budget, accelerating time to market and product adoption in communities that are the most vulnerable and hardest to reach. The Site Bridge network extends reach further into these communities to empower a broader set of patients with some of the highest unmet needs to take part in clinical research to improve health outcomes.

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) on multiple ongoing research studies. While the PI is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study.

The CRC works collaboratively with the entire site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. In addition, the role represents our mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant.

The position will be responsible for specific clinical site activities to maintain the operational excellence required of clinical sites/staff involved in clinical studies and to assure compliance with protocol-specific procedures, data acquisition, and records management. This role will report to the Director, Clinical Site Development Operations and Study Management.

The position is located in Germantown, WI and will be required to be on-site.

This is a (1099) Independent Contractor position and is part-time to begin with potential to move into full-time based on study needs.

• Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines.
• Ensure study feasibility assessments for contracted sponsor-initiated studies.
• Assist the Clinical/Site Ops Leads on the set-up/start-up of research site to prepare for start-up and conduct of clinical trials.
• Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO.
• Consult with Site Leads, sponsor, and CRO to determine the best recruitment practices for site and trials.
• Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies.
• Arrange screening and recruitment of potential study participants by scheduling visits to establish Informed Consent and perform intake assessments according to protocols.
• Create and maintain all essential documents and records related to the study.
• Act as a point of reference for study participants by answering questions and keeping them informed on the study’s progress.
• Oversee and/or manage the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed.
• Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results.
• Direct the request, collection, labeling, storage, or shipment of interventional products.
• Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems.
• Monitor the enrollment status of participants at the site for each specific clinical study.
• Operate as primary contact for sponsors/CROs to schedule and coordinate site visits and answer queries.
• Participate in meetings (Investigator Meetings, Site Trainings, etc.) and seminars to update knowledge of clinical research and related issues.
• Prepare or participate in quality assurance audits and inspections performed by sponsors/CROs, regulatory authorities, or exclusively…