Posted: Apr 02, 2019
This position is accountable for meeting study-specific goals and timelines, collecting data from a variety of sources and recording them into databases for review; simultaneously, addressing and amending ongoing queries from previously reported data. It is critical to be detail oriented to ensure accuracy and integrity of the data. The person in this position prepares for monitoring visits and audits as well as communicates appropriately and effectively with study subjects, investigators, and other team members as necessary. Finally, the position performs clinical duties as assigned based on appropriate licensure and/or completion of competency documentation and team needs. The successful incumbent has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all.
Key tasks include but are not limited to:
• Evaluate and analyze source documentation for case report form completion.
• Database use and management for active and long-term follow up patients.
• Utilize multiple data capture/retrieval systems and interacts with a variety of health care delivery systems to identify, track, analyze and submit subject data.
Data may include but are not limited to paper data, electronic data and biological specimens.
• May assist in processing, tracking, and shipment of biological specimens, including tissue and blood samples.
• Collaborate closely with the CCRP Clinical Research Team, which may include the Principal Investigator (PI), Sub-Investigators and Management team to
ensure that key federal/state/local regulatory objectives are met, and that ethical obligations are kept.
• Work with the clinical research team in preparation for external and internal audits and is responsible for the quality and completeness of subject data.
• Resolve data queries accurately and expediently.
• Enter overdue data and query notifications in data system to ensure timely completion.
• Participate in project-related and departmental meetings as required. May participate in cross-functional teams.
• Adhere to Good Clinical Practices and compliance with all CCRP policies and procedures.
• Complete and maintains certification in Human Subjects Protection training, CITI training, and biosafety training within required timeframes.
• Develop, establishes and maintains productive relationships with CCRP colleagues and all external partners and contacts at affiliate sites.
• May attend relevant symposia, conferences and scientific meetings as necessary.
• Perform other duties as requested.
• Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations
and sponsor protocols.
• Work on multiple research studies simultaneously
• Excellent attention to detail and ability to interpret and master complex research protocol information
• Evaluate study data for protocol compliance.
• Assist Data Operations staff in resolving non-routine data entry issues.
• Provide efficient and complete data collection, processing, and reporting; assures source documentation and data abstraction and entry are being done at the
protocol specified time-points
• Frequent sitting, standing, walking, reading of documents, use of computer monitor screen and mouse, reaching with hands and arms, talking, writing and
• Frequent use of computer, telephone and general office equipment required.
• Problem-solving skills and ability to independently analyze and interpret data is required.
• Clear oral and written communication skills are required for all interactions on behalf of CCRP with the public, physicians, affiliates and staff.
• Bachelor’s Degree preferred or equivalent experience in health research and/or healthcare-related field preferred (oncology experience a plus), or an equivalent
combination of training & experience.
• Knowledge of and experience with basic human anatomy, physiology, and medical terminology
• Highly proficient with multiple computer applications, including but not limited to: Microsoft Office products, particularly Excel, online database
use/maintenance, network file maintenance & management, and custom report generation.
• Working knowledge of Medidata Rave highly desirable
• Experience using health-care based clinical information systems preferred.
• Understanding of current GCP/ICH guidelines and FDA regulations applicable to the conduct of clinical research.
• Excellent written and oral communication skills.
• Detail-oriented with strong organizational and prioritizing skills.
• Must be able to work as a member of a team, manage conflicts and resolve problems effectively.
• Ability to handle competing priorities with diplomacy and enthusiasm in an accurate and timely manner.
• Ability to absorb large amounts of information quickly required.
• Adaptability to changing working situations and work assignments required.
• Ability to exercise independent judgment within generally defined practices and policies. Shows good judgment in interpreting guidelines and in when to seek
support. (willing to ask questions when a task is not fully clear)
• Excellent interpersonal communication skills, organizational skills, and ability to problem-solve, multi-task, and work independently
• Ability to read and understand complex documents (e.g., clinical trial protocols) required.
• Depending on workload, some evening and weekend hours may be required.
• Valid driver’s license; ability to travel to affiliate sites using individual’s own transportation may be required.
CCRP offers an excellent benefits package including health, dental and vision insurance options, a 401K retirement program, nine paid holidays, and generous PTO.
The salary range for this position is $45,000-$50,000 annually