Clinical Research Coordinator II - Division of Ophthalmology

Children's Hospital of Philadelphia•Philadelphia, PA

1d•$58,300 - $72,900

About The Position

Under minimal supervision, substantially coordinate all clinical research activities within the scope of clinical research protocols. Manage day-to-day study activities under the guidance of the principal investigator (PI) or managing study staff. The role includes assignments involving more complex studies.

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 with patient-facing responsibilities must receive an annual influenza vaccine.

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 participants.
Coordinate protocol-related research procedures, study visits, and follow-up care.
Screen, recruit, and enroll patients or research participants.
Maintain study source documents and report adverse events.
Follow good clinical practice (GCP), regulatory requirements, and institutional policies, SOPs, guidelines, and applicable federal, state, and sponsor policies.
Educate subjects and families about the protocol and study interventions.
Prepare, submit, manage, and maintain essential regulatory documents, including IRB and FDA documents, and monitor the regulatory status of 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 study close-out activities as appropriate.
Coordinate research or project team meetings and support study-team communications and outreach.
Collect, process, and ship laboratory specimens.
Schedule subject visits and procedures.
Retain records and archive documents after study close-out.
As applicable, manage study finances, sponsor invoicing, and study-subject billing issues.
Develop advertisement materials and serve as a liaison among research subjects, investigators, the IRB, sponsors, and healthcare professionals.
Organize or lead study-related meetings locally or across teams for multi-site projects.
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 and related documents, such as study administration manuals.
Develop case report forms.