Global Research Services (GRS) helps support and conduct clinical research in low-resource settings around the world. Our team includes clinical project managers, clinical research associates, research assistants, laboratory technologists, laboratory auditors, document specialists and instructional designers.
With culturally sensitive and multilingual employees in the United States, Africa, Asia, Latin America and Europe, GRS offers the following services to government and private sponsors:
- Project management
- Protection of participants’ safety and rights
- Site identification, evaulation and development
- Site monitoring, management and training
- Research operations
- Laboratory capacity building, auditing, and training
- Logistical support
GRS seeks an experienced CTA to provide support to our Clinical Research Project Managers, interacting with other parts of the organization and clinical systems to contribute to the strong implementation of clinical research.
- Responsible for the overall coordination and management of clinical projects/studies from start-up through close-out activities.
- The CRPM II is responsible for the management of complex, multicenter, multinational clinical studies, including FDA-regulated clinical trials.
- Directs the technical and operational aspects of clinical research efforts, including providing supervisory and mentoring support to other clinical research staff, to ensure the successful completion of clinical studies.
- Manages complex relationships with a diverse group of collaborators representing donor agencies, local government, non-government organizations, industry, and academia.
- Works with major functional area leads to identify and evaluate fundamental issues on the project, makes sound business decisions and ensures solutions are appropriately vetted and implemented.
- Works to ensure all project deliverables meet the sponsor's time/quality/cost expectations.
- Works in collaboration with other functional area leads providing accurate labor forecasts, reviewing pass-through costs and ensuring timely invoicing.
- Effectively creates operational project plans tailored to the particular needs of each assigned study.
- Collaborates with centralized, remote monitoring units to ensure project progress and deliverables meet or exceed contractual requirements.
- Ensures that all clinical study management and project deliverables are completed to the sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with Standard Operating Procedures (SOPs), policies and practices.
- A minimum of 8+ years of previous experience in clinical research project management, possessing the knowledge, skills, and abilities to perform this job.
- Minimum of 5 years of experience managing clinical studies in resource-constrained settings.
- Must have commercial CRO experience.
- Global project management experience.
- Proficiency in Microsoft Office, and spreadsheets required.
- Able to delegate, effectively prioritizes own and workload of project team members.
- Displays effective communication skills (listening, oral, and written) and can communicate in the English language (oral, written).
- Possesses sound interpersonal skills, is flexible and adapts to changing situations.
- Articulate, professional and able to communicate in a clear, positive concise manner with sponsors and staff.
- Must be able to read, write and speak fluent English.
FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.