Clinical Research Coordinator II - Hematology

Children's Hospital of Philadelphia•Philadelphia, PA

6d•$58,300 - $72,900

About The Position

The Children’s Hospital of Philadelphia’s Division of Hematology is hiring a full-time clinical research coordinator to work on clinical studies involving thalassemia and other red blood cell disorders and coordinate sample collection and processing for the Division of Hematology Biorepository. Specific research projects will be discussed during the interview. The role includes regular patient interaction in a clinical setting and opportunities to build relationships with patients and families. It also includes basic wet-lab work to process samples and run simple assays, and may offer opportunities to travel to hematology conferences and participate in authorship and publishing. Research staff are required to attend weekly disease program clinical meetings, with opportunities to attend weekly Hematology Divisional Clinical Conference and Department of Pediatrics Grand Rounds.

Requirements

Bachelor’s degree.
At least two years of clinical or research coordination experience.
Basic knowledge of IRB processes and human-subject protection.
Excellent verbal and written communication skills.
Strong time-management skills.
Ability to collaborate with stakeholders at all levels.

Nice To Haves

Master’s degree in a related field.
At least three years of clinical or research coordination experience.

Responsibilities

Adhere to an IRB-approved protocol.
Participate in the informed consent process for study subjects.
Support the safety of clinical research patients and participants.
Coordinate protocol-related research procedures, study visits, and follow-up care.
Screen, recruit, and enroll patients and research participants.
Maintain study source documents and report adverse events.
Understand and follow good clinical practice (GCP) and regulatory requirements.
Educate subjects and families about protocols and study interventions.
Comply with institutional policies, standard operating procedures, guidelines, and applicable federal, state, and sponsor policies.
Prepare, manage, submit, and maintain essential regulatory documents, including IRB and FDA documents, and monitor the regulatory status of assigned projects.
Register studies on ClinicalTrials.gov as appropriate and maintain ClinicalTrials.gov records.
Complete paper and electronic case report forms and address data queries.
Facilitate pre-study, site qualification, study initiation, monitoring, and close-out activities as appropriate.
Coordinate research and project team meetings.
Collect, process, and ship laboratory specimens.
Schedule subject visits and procedures.
Retain records and archive documents after study close-out.
As assigned, manage study finances, including sponsor invoicing and resolution of study-subject billing issues.
Develop advertisement materials and act as a liaison among research subjects, investigators, the IRB, sponsors, and healthcare professionals.
Organize or run study-related meetings locally or across teams for multi-site projects, and support study-team communications and outreach.
Provide training to junior staff on conducting research studies.
Document investigational product (drug or device) accountability and conduct self-monitoring and self-audits.
Develop informed consent documents and draft or edit IRB protocols and related documents, such as study administration manuals.
Develop case report forms and take assignments involving more complex studies.