Senior Clinical Research Coordinator

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 laboratory-based study in South Africa, as well as other studies as assigned.

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 scientific writing skills, 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

• Write, develop, and manage a range of scientific publications, including reports, articles, and other written materials, from initial concept through final production, ensuring content is accurate, well-organized, and aligned with academic standards.

• 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

• 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

Required Qualifications:

• 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.
• 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 Certifications:

• 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

Preferred Qualifications:

• 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