Clinical Operations Manager

SiteBridge Research, Inc.; Chapel Hill (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

SiteBridge Research, Inc. is seeking a Clinical Operations Manager to oversee CRCs and site staff across multiple sites within our remote network. This role requires deep industry knowledge and the ability to manage staffing, study readiness, and performance metrics.

Travel up to 30% is required. The Operations Manager will support start-up, maintenance, and close-out activities, partner with cross-functional teams, and ensure ICH/GCP and SOP compliance across sites.

Qualifications

• Bachelor's degree minimum: a combination of education and related technical/professional experience may be substituted for the degree requirements and will be considered on a case-by-case basis
• Minimum of four (4) years of clinical research experience.

Responsibilities

• Provide day-to-day oversight of CRCs and site staff across multiple sites or satellite locations, ensuring study readiness and protocol compliance.
• Own site and CRC performance against key performance metrics, identifying gaps and implementing corrective actions.
• Drive enrollment planning and ensure sites meet recruitment goals for their studies.
• Manage CRC hiring, onboarding, training, performance management, and retention across all sites.
• Support study start-up, maintenance, and close-out activities across assigned sites.
• Identify barriers to timely study activation and partner with teams to implement solutions.
• Collaborate with recruitment, budget, and finance teams to drive site success and forecast financial performance at the site level.
• Fill site and study level needs as necessary to meet sponsor requirements.
• Track activities to ensure SOPs and regulatory compliance.
• Prepare for audits/inspections and follow up as needed.
• Participate in trainings, investigator meetings, site trainings, and conferences.

Education

Bachelor's degree minimum

Minimum of four (4) years of clinical research

Job description

SiteBridge Research IncFounded in 2021, SiteBridge Research is an integrated research organization, focused on building a national network of small and community medical practices to deliver world-class industry sponsored clinical research studies on time and on budget, accelerating time to completing clinical trials, accelerating time to market and product adoption in communities that are often underrepresented and difficult to reach. SiteBridge Research extends reach further into these communities to empower patients with some of the highest unmet needs to take part in clinical studies to improve inclusivity in clinical research and to improve overall health outcomes.

SiteBridge Research IncFounded in 2021, SiteBridge Research is an integrated research organization, focused on building a national network of small and community medical practices to deliver world-class industry sponsored clinical research studies on time and on budget, accelerating time to completing clinical trials, accelerating time to market and product adoption in communities that are often underrepresented and difficult to reach. SiteBridge Research extends reach further into these communities to empower patients with some of the highest unmet needs to take part in clinical studies to improve inclusivity in clinical research and to improve overall health outcomes.

Job Description: The Clinical Operations Manager is an experienced clinical research professional who provides oversight and support to Clinical Research Coordinators (CRCs) and site staff across multiple sites or satellite locations within our site network. This role requires in-depth industry understanding, knowledge, experience, and flexibility to make informed and effective decisions independently. The Operations Manager is responsible for site oversight, including study readiness, CRC and site performance, and overall site performance against key performance metrics for each assigned study. The Operations Manager maintains a staffing plan for the resourcing and utilization of site operations team members across multiple locations or larger sites to achieve performance objectives, identify opportunities or gaps, and implement plans accordingly. This role also supports study start-up, maintenance, and close-out activities, and partners cross-functionally with recruitment, budget, and finance teams to drive site success. In addition, and most importantly, this role represents the SiteBridge Research 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 maintain the operational excellence required of clinical sites/staff involved in clinical studies and ensure ICH/GCP and SOP compliance. The person in this role will report to the Executive Director of Site Operations. The position is remote with up to 30% travel at time during peak study activities for candidates with prerequisite experience. Responsibilities

• Provide day-to-day oversight of CRCs and site staff across multiple sites or satellite locations, ensuring study readiness, protocol compliance, and consistent execution across the portfolio
• Own site and CRC performance against key performance metrics for each assigned study, identifying gaps early and implementing corrective action plans
• Drive accountability for patient enrollment, ensuring sites own the enrollment plan to meet recruitment goals for their specific studies
• Responsible for CRC hiring, onboarding, training, performance management, and retention across all assigned sites and satellite locations
• Support project start-up, maintenance, and close-out activities across assigned sites, including study start-up and close-out, recruitment, and regulatory submissions
• Identify barriers to timely study activation, efficient coordination, and site performance, and partner with appropriate teams to identify and implement solutions
• Partner cross-functionally with recruitment, budget, and finance teams to drive site success and support forecasting and financial performance at the site level
• As necessary, step in and fill site and study level needs including but not limited to site set-up and CRC duties to meet SiteBridge and sponsor needs
• Evaluate and communicate metrics of all activity related to assigned sites and studies, and provide summary findings and recommendations to leadership
• Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies
• Prepare, participate in, and follow-up on audits/inspections as needed, including direction for audit prep and any required follow up post audit
• Participates in required training and education programs
• Participate in meetings (ie., Investigator Meetings, Site Trainings, Conferences) and seminars to update knowledge of clinical research and related issues as necessary
• Other duties and support as assigned related to site and study operations
• Travel is required (up to 30%) for projects related to site development and operations

Qualifications/Required Experience

• Bachelor's degree minimum: a combination of education and related technical/professional experience may be substituted for the degree requirements and will be considered on a case-by-case basis
• Minimum of four (4) years of clinical research