Manager, Clinical Research

Children's Healthcare of Atlanta•Brookhaven, GA

1d•Onsite

About The Position

Provides effective 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.

Requirements

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
Bachelor's degree
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
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
In-depth understanding and ability to provide leadership and guidance regarding state and/or federal regulatory guidelines related to research
Ability to exercise independent judgment in doing medical summaries (Delete)
Working knowledge of information systems, including PC and Microsoft Office (Word, PowerPoint, and Excel) and statistical software
Good written and oral communication, interpersonal, analytical, conflict resolution, and problem-solving skills, as well as the ability to work and communicate effectively with all levels of management.
Skilled at staff recruitment, retention, and development
Able to maintain good relationships with physicians, other medical providers, and research team members
Ability to exercise independent judgment
Strong negotiating skills
High degree of clerical accuracy with attentiveness to detail

Nice To Haves

Advanced degree
3 years of experience in managing staff
Experience in financial management
Pediatric Advanced Life Support (PALS) certification
CCRP

Responsibilities

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 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 operational and 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 Pre-Award Research Administration in pre-award process, including negotiating and preparing research budgets and routing processes.
Collaborates with appropriate financial team contacts to manage grants/contracts accounts post-award processes related to clinical research functions.
Collaborates with Grants Accounting and Post-Award Research Administration in post-award activities, including ensuring invoices are submitted, payments received, and revenue released appropriately.
Collaborates with Research Financial Operations in pre- and post-award analysis.
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 study team members, 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.