Clinical Research Coordinator II - PolicyLab

Children's Hospital of Philadelphia•Philadelphia, PA

6d•$28 - $35

About The Position

Under minimal supervision, substantially coordinates clinical research activities for the Parenting with Depression (PWD) Study and potential future studies. This part-time position manages the day-to-day activities of the PWD study under the guidance of James Guevara, MD, MPH, the study’s PI, and works with research staff and other investigators while supervising research trainees as appropriate. The PWD study is an ongoing longitudinal study of a social media-based parenting program for mothers experiencing postpartum depressive symptoms. The work encompasses regulatory and administrative activities, study conduct, analysis of study findings, and dissemination of findings.

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 IRB-approved protocols and participate in the informed consent process.
Support participant safety; coordinate protocol-related procedures, study visits, and follow-up care; and screen, recruit, and enroll participants.
Maintain study source documents and report adverse events.
Educate participants and families about the protocol and study intervention, and comply with institutional policies, SOPs, guidelines, and applicable federal, state, and sponsor policies.
Prepare, manage, submit, and maintain essential regulatory documents, remain aware of project regulatory status, and register studies on ClinicalTrials.gov as appropriate.
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; schedule participant visits and procedures; and collect, process, and ship laboratory specimens.
Retain records and archive documents after study closeout.
Potentially manage study finances, sponsor invoicing, and participant billing issues; develop advertising materials; and serve as a liaison among participants, investigators, IRB, sponsors, and healthcare professionals.
Support study-team communications and outreach; organize or run study-related meetings locally or across teams for multisite projects; and train junior staff in research study conduct.
Document investigational product accountability and perform self-monitoring and self-audits.
Potentially develop informed consent documents, draft or edit IRB protocols and related documents, maintain ClinicalTrials.gov records, and develop case report forms.
Work on assignments that include more complex studies.