The Clinical Research Manager provides leadership and oversight for all aspects of clinical research occurring within the specified program, including data management, enrollment and recruitment, feasibility analysis, and financial management. Provides guidance and assistance in protocol development. Manages approved research studies and other related protocols. Manages Clinical Research Coordinators, Clinical Research Nurses, and other departmental research staff. Acts as a resource for the medical staff and community; providing educational information and expertise in research methodologies and fostering multidisciplinary research throughout Children’s Healthcare of Atlanta.
Children’s is a national leader and model for pediatric medicine, but we not only offers superior care to our patients, we also offer a highly-esteemed, professional workplace for our employees and a culture of respect and caring. We are consistently ranked among the “Best Places to Work” by local and national publications such Fortune, Working Mother and the Atlanta Journal-Constitution. We recognize the importance of work-life balance for our employees, and we are constantly identifying programs and services to make life easier and help them achieve their career goals. Children's researchers are engaged in more than 600 active studies in the community to improve the delivery of pediatric care in 28 specialty areas, with an emphasis on hematology/oncology, blood and marrow transplantation and cardiology. Learn more about how to register a clinical trial.
- Bachelor's degree
- Basic Life Support (BLS) within 30 days of employment if role requires patient contact
- ARUP Handling, Packaging and Shipping Infectious Substances or similar within 30 days of employment if role requires specimen acquisition
- Collaborative Institutional Training Initiative (CITI) within 30 days of employment
- 1 year of supervisory experience
- 5 years of experience in managing clinical research trials with demonstrated evidence of success regarding the conduct of clinical trials, research principles, and methodologies/study design
- Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of employment
- Advanced degree
- 3 years of experience in managing staff
- Experience in financial management
- Pediatric Advanced Life Support (PALS) certification
KNOWLEDGE SKILLS & ABILITIES*
- In-depth understanding and ability to provide leadership guidance of state and federal regulatory guidelines related to research
- Ability to exercise independent judgment in doing medical summaries
- Working knowledge of information systems, including PC and Microsoft Office (Word, Access, PowerPoint, and Excel) and statistical software
- Good written and oral communication, interpersonal, analytical, conflict resolution, and problem-solving skills
- Skilled at staff recruitment, retention, and development
- Able to maintain good relationships with physician and other medical providers
- Ability to exercise independent judgment
- Strong negotiating skills
- High degree of clerical accuracy with attentiveness to detail
- Serves as manager and institutional resource for the Research department.
- Facilitates multidisciplinary research throughout Children’s Healthcare of Atlanta by actively sharing information, seeking, and identifying opportunities for collaborative projects.
- Works with Manager, Research Compliance to ensure program-specific research is conducted in compliance with local, state, and federal regulations, policies, standard operating procedures, and guidelines as well as Children’s Healthcare of Atlanta policies and guidelines.
- Develops and maintains relationships with leadership in other departments to assure appropriate resources are accessible.
- Oversees financial tasks related to research and the Clinical Research department.
- Demonstrates fiscal responsibility in operating budget preparation, National Institutes of Health budget preparation, contract budget preparation, monthly analysis, and compliance to budget guidelines.
- Provides oversight for the grant application process for all program-specific grants and clinical research/trials in collaboration with appropriate personnel and ancillary departments.
- Collaborates with Manager, Research Finance to manage the grant/contract pre-award process, including negotiating and preparing research budgets and routing processes.
- Manages grants/contracts accounts post-awards with appropriate financial team contacts.
- Collaborates with Manager, Grants Accounting to manage grant/contract post-award activities, including ensuring invoices are submitted, payments received, and revenue released appropriately.
- Maintains program-specific databases for financial and goal performance.
- Maintains records of and primary accountability for new protocols, amendments, and Institutional Review Board activity, including submission and coordination of protocols throughout the grants, contracts, finance, and Institutional Review Board processes.
- Analyzes the feasibility of establishing new research and/or institutional protocols.
- Oversees the evaluation of patients for inclusion in specific protocols by Research Coordinators and nurses, in planning therapy, and in monitoring compliance and protocol management.
- Manages clinical and non-clinical staff and guides direct patient care to conduct research protocols in the inpatient and outpatient care environments as part of a study protocol.
- Oversees the conduct of research procedures.
- Provides leadership and training to guide patient assessment and facilitate care, including vital signs, medication administration, venous access, phlebotomy and specimen acquisition, and conduct of research procedures in the inpatient and outpatient care environments as part of a study protocol.
- Responsible for all aspects of managing and leading a team including: interviewing, hiring, training, developing, directing work and processes, managing performance, recognizing, and rewarding employees.
- Mentor team members to encourage personal and professional growth.
- Encourage ongoing skill development by providing opportunities for continued education.
Requisition #: 22776