Implementation Consultant

Summary The Clinical Site Manager oversees day-to-day operations at clinical research sites to optimize performance and drive achievement of organizational goals. This role ensures that both sponsors and participants receive high-quality service, that contractual obligations are met, and that all work is completed in a professional, ethical, and compliant manner. The Clinical Site Manager collaborates closely with site leadership and investigators to plan and execute studies, resolve operational issues, and continuously improve site quality, recruitment, and retention. Responsibilities Review and discuss awarded studies with the Principal Investigator to support leadership in making informed decisions about which studies to conduct. Collaborate with site leadership to assess and plan staffing needs required for successful study conduct. Work with site leadership to ensure the site has appropriate space, staff, and time to optimize study conduct, particularly participant recruitment and retention. Manage clinic operations by working closely with site leaders on staff management and resource allocation. Demonstrate strong knowledge of clinical research, sponsor expectations, and industry standards, and use this knowledge to guide site operations. Lead site staff in ongoing professional growth and high performance, fostering a culture of excellence. Participate in hiring high-quality candidates for positions within the site and ensure a thorough onboarding process. Ensure that site staff are qualified and adequately trained for their roles and assigned duties. Work with site leadership to plan for upcoming studies and ensure operational readiness. Ensure that site staff and investigators are informed of awarded studies and understand their responsibilities. Monitor staff performance, hold staff accountable to role expectations, and provide timely performance feedback. Ensure staff comply with study protocols, FDA regulations, ICH guidelines, and internal standard operating procedures and policies. Monitor overall site quality and performance and develop and implement solutions to optimize outcomes. Monitor study needs and provide hands-on support to staff with study conduct and management as needed. Manage staff schedules to optimize site performance and ensure adequate coverage for study activities. Collaborate with site leadership to address disciplinary issues and HR concerns such as misconduct, policy violations, and workplace conflict. Ensure staff compliance with the company Employee Handbook and organizational policies. Build and maintain strong working relationships with investigators in collaboration with site leadership. Ensure adequate investigator coverage to support optimal site visits and study conduct. Collaborate with investigators to promote study success and resolve operational or clinical issues. Manage site quality control processes, including monitoring adherence to SOPs and implementing corrective actions when necessary. Monitor site staff to ensure the highest quality performance and adherence to Good Clinical Practice and FDA regulations and guidance, taking immediate corrective actions as needed. Serve as an active team member, communicating effectively and professionally with other team members in a timely manner. Represent the site and organization in a professional, ethical, and positive manner and promote harmony and professionalism in the workplace. Acquire and maintain required training, including SOPs, processes, and policies training, Good Clinical Practice training, and IATA Shipment of Hazardous Goods training (if applicable), according to defined schedules. Participate in study-specific training as required and maintain any relevant medical licenses and certifications. Ensure the site is fully prepared for study conduct, including facilities, staff, documentation, and supplies. Ensure appropriate staff attend investigator meetings and site initiation visits and are adequately briefed on study requirements. Ensure all staff participating in a trial receive appropriate training for their delegated tasks. Oversee timely creation and review of source documents to support accurate data capture. Work with regulatory staff to manage essential documents and complete site-level regulatory duties, including continuing reviews and study closeouts. Disseminate study-related information to site personnel and potential participants in a clear and timely manner. Ensure the site obtains all required documents and equipment needed to conduct each study. Ensure sponsor and IRB approvals are obtained prior to study initiation and maintained throughout the study. Communicate with sponsors and vendors in a timely and professional manner to support study progress. Coordinate with recruiting departments and other resources to support participant recruitment and retention. Ensure recruitment goals for all studies are met or exceeded through effective planning and oversight. Ensure all study-related activities are completed in accordance with the protocol, FDA regulations, ICH guidelines, and organizational expectations. Ensure information entered into case report forms is complete and accurate and that data queries are resolved efficiently. Ensure study documents are complete, current, and filed correctly to support audit readiness and regulatory compliance. Oversee laboratory procedures associated with studies to ensure they are completed accurately and in compliance with protocols. Manage study supplies, ensuring availability, proper storage, and inventory control. Ensure study closeout activities are planned and completed efficiently and in accordance with sponsor and regulatory requirements. Perform other duties as assigned to support site operations and organizational goals. Essential Skills Ability to communicate effectively in both verbal and written form with staff, investigators, sponsors, and other stakeholders. Ability to read or learn to read scientific language and synthesize complex information into practical guidance for site operations. Willingness and ability to adhere to instructions, study protocols, and regulatory requirements. Demonstrated leadership skills with the ability to guide, motivate, and hold staff accountable. Minimum of 3 years of experience in clinical research or a closely related industry. Supervisory or management experience, or clearly demonstrated leadership capabilities in a clinical or research setting. Experience with regulatory processes, clinical procedures, sponsor interaction, and human resources (preferred but strongly beneficial). Ability to work remotely while being available during standard business hours. Ability to lift up to 15 pounds on occasion. Ability to commute between multiple site locations as needed. Willingness and ability to travel up to approximately 20% of the time. Additional Skills & Qualifications Background in clinical research coordination (CRC) or related clinical research roles. Experience as a Clinical Research Site Manager or in a similar site leadership position. Familiarity with Good Clinical Practice (GCP) guidelines and FDA regulations governing clinical research. Experience with sponsor communication and monitor interactions, including responding to queries and implementing feedback. Experience with regulatory documentation, continuing reviews, and study closeout processes. Exposure to human resources matters such as performance management, discipline, and conflict resolution within a clinical setting. Comfort with reading scientific protocols and translating requirements into operational workflows. Training in IATA Shipment of Hazardous Goods (if applicable), with willingness to maintain certification on a defined schedule. Commitment to maintaining medical licenses and professional certifications as required by role and jurisdiction. College or specialized degree in a health, science, or research-related field is preferred. Strong organizational and time-management skills, with the ability to manage multiple studies and priorities. Ability to build and develop high-performing teams, particularly in newer or growing sites. Interest in pediatrics and endocrinology clinical research and willingness to support studies in these therapeutic areas. This is a site-based role supporting two clinical research sites located in the Richmond, VA and Midlothian, VA areas. The work environment centers on an experienced clinical research site network with a focus on pediatric and endocrinology studies. You will collaborate closely with investigators, coordinators, regulatory staff, and other research professionals in a clinical setting that emphasizes compliance, quality, and participant safety. The position involves a combination of on-site work and remote responsibilities during standard business hours, with regular commuting between local sites and occasional travel of less than 20%. The environment offers significant opportunity to build and develop your own team, shape site operations, and make a meaningful impact on the success and growth of newer research sites. Job Type & Location: This is a Permanent position based out of Richmond, VA. Pay and Benefits: The pay range for this position is $80000.00 - $120000.00/yr. Relocation assistance is available. The relocation amount is still TBD and will be paid as a bonus on the employee's first paycheck. #J-18808-Ljbffr