The Senior Clinical Research Coordinator (CRC) is an experienced professional who independently coordinates and is accountable for the overall administration of one or more clinical and implementation studies, requiring advanced-level knowledge and skills. The Senior CRC will support two studies, a domestic industry collaboration around diagnostic assay development, and a drug-resistant tuberculosis cluster randomized pragmatic trial in South Africa, as well as other studies as assigned.
On the drug-resistant tuberculosis cluster randomized pragmatic trial, the Senior CRC will report to the Principal Investigator and will have central responsibility for ensuring the overall coordination, administration, and monitoring of the trial, which includes close collaboration with academic research partners, public health officials, commercial entities, and non-governmental actors in multiple international settings.
The senior CRC will be responsible for managing study communications across multiple stakeholders, ensuring timely implementation of research activities, overseeing operational and administrative functions, and managing other team members, as needed. Travel will be required to study sites, and to international study locations (South Africa, and potentially other sites). The position requires strong program management skills, flexibility and adaptability to move between studies in international and domestic settings, and a willingness to complete tasks regardless of level of responsibility.
Knowledge and experience working on domestic and/or international research studies focused on TB, HIV and COVID-19 is highly desired. Under the direction of Project Director’s/Principal Investigator’s, the senior CRC will engage in the following activities: Develop plans to ensure research commitments are met, and ensure timely implementation of research activities Provide high-level communications and facilitation support to ensure collaboration among multiple study stakeholders Develop and implement knowledge management systems that are accessible to internal and external study stakeholders Manage other team members, deliverables, timelines, and dissemination of reports and publications Ensure committee on human research approval and compliance Manage contract negotiations with study partners and provide contract oversight Provide support to manage study databases Conduct statistical analyses and database management fundamental to project monitoring and/or summary (mainly descriptive statistics) Support principal investigators with budget monitoring and procurement of study supplies, as needed Support principal investigators to troubleshoot any issues that arise within the pragmatic trial or the implementation research study Responsibilities % of time Essential Function (Yes/No ) Key Responsibilities (To be completed by Supervisor) 40 Yes Research Operations Management: Develop plans to ensure research commitments are met and ensure timely implementation of research activities.
Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables Assist with scientific writing and production of publication-ready reports. Design and perform ad-hoc performance analysis of the projects and the project staff. Develop project-related presentation material for study.
Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.) Support development of study specific websites. 40 Yes Clinical Trials/Research Project Management: Negotiate pre-trial agreements, budget, and supply chains; work with Research Services Analyst and Industry Contracts to execute agreements; set up ancillary departments, train staff as needed, assign tasks, create documentation, and ensure in-country research law compliance.
Ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, and track enrollment; lead staff to ensure proper close-out of studies, and ensure that documentation and storage of study files meet legal requirements. Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research. Ensure all CHR documents are up to date.
Oversee preparation of new CHR applications; arrange paperwork for renewal of existing protocols; respond to CHR requests for revisions; and coordinate protocol changes with study sponsors. Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the CHR in a timely manner. Respond to requests and reviews of studies from sponsors, study monitors, and other entities, including complex audits of study performance.
Coordinate management processes including regular meetings, remote communications, and site visits. Ensure appropriate processes are in place for planning and executing site visits including international and local travel, insurance and security plans. Coordinate all aspects of single or multiple research studies through strong administration and ensuring efficiency, compliance and safety.
Working closely with administrators on required documentation for reimbursement and auditing. Create and monitor a project management plan for study implementation including all major milestones. Work with the PI and other faculty and staff to ensure compliance with deadlines.
Responsible for overall coordination of advisory committees and communications with other multi-site organizations. Develop and implement QA/QC processes and ensure compliance to GCP, POPI Act (in South Africa) and other study regulations. Perform site visits to evaluate efficiency and compliance; implement QA and QI processes as needed to improve site study conduct. 10 HR Support: In collaboration with leadership, assist with recruitment, training and coordination of research staff activities.
Provide guidance to research staff to help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, and data entry. Train others in international, federal and local research laws and guidelines. Assist with hiring and interview processes.
Onboard new research staff and provide training on all aspects of the research activities. Help with personnel needs, as requested. 10 Financial Management: Maintain awareness of budget and subcontract status and work closely with post-award staff to ensure proper budget use, revision and expenditure. Monitor budgets, invoices, and reimbursements, as needed.
Review budget reports on a routine basis and ensure billing is appropriate and accurate, as requested. Along with the PI, create and maintain the annual study budget, monitoring all items posted on ledgers, and ensuring that future budget projections are consistent with remaining funds. On the pragmatic trial, ensure that the use of research funding is in compliance with funding agency protocols.
Assist PI in grant development, focusing on budget development. 10 0% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.) Required
BS/BA degree in a related area and/or equivalent experience/training. Sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training. Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire.
In-depth knowledge and experience with clinical research and/or implementation research contracts and grants, clinical trials, protocols, and complex visit structures Project management skills to oversee the administrative operations of clinical trials and implementation research activities Strong communication and facilitation skills, with experience effectively supporting multi-stakeholder collaborations Experience working in an international research setting and demonstrated experience communicating and building relationships with international partners, including Ministries of Health, commercial entities, faculty based at international Universities or research sites, and project staff Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills Experience developing and implementing project plans/schedules and motivating teams to meet deadlines Intermediate to advanced database management skills, with ability to develop complex spreadsheets independently Highly proactive, attentive to detail, well-organized, proven ability to multitask and meet deadlines Travel up to 20% to domestic sites and 4-6 weeks per year to international sites (South Africa, etc.).
Required Licenses and/or
Certification by the Society of Clinical Research Associates or Association of Clinical Research Professionals, or ability to obtain certification within one year of date of hire
Master’s degree in public health, public policy or related field Knowledge and experience in TB, HIV and/or COVID-19 research Proficiency in use of statistical software Experience with grant application procedures, personnel documentation, contract generation and subcontracting
Full time · Day shift