Clinical Research Coordinator I - Oncology
About The Position
Dr. Richard Aplenc is seeking a research coordinator I to provide clinical coordinator and data support to ongoing cohort studies of pediatric acute leukemia. The coordinator will be expected to perform detailed, standardized chart abstractions, serve as resource for other staff performing chart abstractions, and develop the capacity to provide data management support for this and other projects. Additional tasks may include providing support for ongoing prospective patient studies, including biologic sample handling. The estimated division of duties is 80% chart abstraction/chart abstraction support and 20% support for other research activities. The coordinator will be expected to be able to interact professionally and independently with outside investigative teams and institutions participating in these cohort studies.
Requirements
- High School Diploma / GED - Required
- At least two (2) years of clinical or research related experience - Required
- Basic knowledge of IRB and human subject protection
- Strong verbal and written communications skills
- Strong time management skills
- Ability to collaborate with stakeholders at all levels
Nice To Haves
- Bachelor's Degree - Preferred
- At least three (3) years of clinical or research related experience - Preferred
Responsibilities
- Adhere to an IRB approved protocol
- Participate in the informed consent process of study subjects
- Support the safety of clinical research patients/research participants
- Coordinate protocol related research procedures, study visits, and follow-up care
- Screen, recruit and enroll patients/research participants
- Maintain study source documents
- Under the supervision of PI Report adverse events
- Understand good clinical practice (GCP) and regulatory compliance
- Educate subjects and family on protocol, study intervention, etc.
- Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and with HIPAA and management of confidential materials
- Must comply with federal, state, and sponsor policies
- For multi-site studies or collaborations, support communication and meeting scheduling across teams
- Manage essential regulatory documents
- Register study on ClinicalTrials.gov as appropriate
- Complete case report forms (paper & electronic data capture) and address queries
- Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie,DSMB, independent safety officer)
- Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
- Facilitate study close out activities as appropriate
- Coordinate research/project team meetings
- Collect, process and ship samples as applicable to the protocol
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
Benefits
- Annual influenza vaccine
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
