Global Solutions Network (GSN), a federal government contracting firm, presents this full time, long-term position supporting GSN's customer at the National Institutes of Health (NIH). This position provides a competitive salary and comprehensive benefits.

If interested, please provide an up-to-date resume.

Responsibilities.

• Manage clinical protocols by assisting in training the study team and other staff members, oversees compliance to protocol, develop and adhere to relevant standard operating procedures (SOPs); manage quality control, completion, and submission of study related documents; help in preparation, submission and maintenance of IRB, FDA, and/or other regulatory documents and research correspondence. 
• Assist in development of informed consent and screening materials. 
• Schedule and oversee study visits to NIH as needed. 
• Interview, screen, recruit and enroll patients in IRB approved clinical trial protocols. 
• Obtain informed consent/assent and addresses complex ethical and legal implications of same. 
• Perform quality assurance and quality control activities as they relate to protocol adherence, protocol monitoring, data collection, data abstraction, and data analysis and assures standard operating procedures reflect the highest standards of data integrity and patient safety. 
• Use advanced communication skills to problem solve complex or unpredictable situations and to improve processes and services to patients and colleagues. 
• Maintain study subject databases; oversee data collection and management including the collection of source documents, using, and developing Case Report Forms (CRFs), and ensuring that they are complete and accurate. 
• Contribute to developing educational materials and educate the community and other research professionals regarding studies and related research issues. 
• Assist with training staff members. 
• Receive patient care phone calls, furnish the requested information, or refer callers to the appropriate staff members.
• Assist in medical documentation. Recruit volunteers for all protocols and collect and report census for all open protocols. 
• Abstract medical information from medical history, medications, and preexisting conditions for new participants. 
• Build and maintain excellent communication with Principal Investigators and others needed to conduct quality research to foster an excellent reputation of site research. 
• Ensure efficient monitoring of all trials by ensuring that the data is clean and entered. 

Qualifications.

• Bachelor’s degree in nursing. 
• Licensed as a nurse in the state of Maryland. 
• Minimum of 9 years of experience in clinical research setting with protocols and clinical trials is required. 
• Knowledge of federal regulatory requirements pertaining to clinical research. 
• Knowledge of Good Clinical Practice (GCP). 
• Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient’s medical records. 
• NIH clinical trials experience preferred. 
• This position and duties may be conducted remotely upon approval. 

Global Solutions Network, Inc. (GSN) is an Equal Employment Opportunity (EEO) employer. It is the policy of the GSN to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected US veteran or disabled status, or genetic information.