Clinical Research Coordinator II - Hill Lab

Children's Hospital of Philadelphia•Philadelphia, PA

1d•$58,300 - $72,900

About The Position

Under minimal supervision, substantially coordinate clinical research activities within the scope of clinical research protocols and manage day-to-day study activities under the guidance of the principal investigator or managing study staff. The Hill Research Lab in the Division of Allergy and Immunology seeks a coordinator with excellent communication skills and a warm disposition to assist with recruitment for human studies focused on atopic diseases, including eosinophilic esophagitis, asthma, and IgE food allergies, as well as irritable bowel syndrome. The coordinator screens, consents, and enrolls research subjects under applicable IRB protocols, transports blood samples from clinical locations to designated laboratories, and occasionally transports tissue samples from the operating room to the Hill lab. The role functions independently and is suited to someone committed to a career in research.

Requirements

Bachelor's degree required.
At least two years of clinical or research coordination experience required.
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.
Employees working in patient-care buildings or in patient-facing roles must receive an annual influenza vaccine as a condition of employment.

Nice To Haves

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

Responsibilities

Adhere to IRB-approved protocols.
Participate in the informed consent process for study subjects.
Support the safety of clinical research patients and research participants.
Coordinate protocol-related research procedures, study visits, and follow-up care.
Screen, recruit, and enroll patients and research participants.
Maintain study source documents.
Report adverse events.
Understand and follow good clinical practice (GCP) and regulatory compliance requirements.
Educate subjects and families about protocols, study interventions, and related matters.
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 regulatory status for projects within the role's scope.
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, including transporting blood samples to designated laboratories and occasional tissue samples to the Hill lab.
Schedule subject visits and procedures.
Retain records and archive documents after study closeout.
Manage study finances, including sponsor invoicing and resolving study-subject billing issues, as assigned.
Develop advertisement materials.
Act as a liaison among research subjects, investigators, the IRB, sponsors, and healthcare professionals.
Organize or lead study-related meetings locally or across teams for multisite projects.
Support study-team communications and outreach.
Train junior staff on the conduct of research studies.
Document investigational product (drug or device) accountability.
Perform self-monitoring and self-audits.
Develop informed consent documents and draft or edit IRB protocols or related documents, such as study administration manuals.
Develop case report forms.
Work on more complex studies.