Clin Research Coordinator Ii : 65003

Clin Research Coordinator Ii : 65003
Company:

(Confidential)


Clin Research Coordinator Ii : 65003

Details of the offer

LOC_WOOD_CTR:Wood BuildingReq ID:52641 Shift: Days Employment Status:Regular : Full Time

Job Summary 13;

Important Notice: Thank you for your interest in the Childrens Hospital of Philadelphia. Due to the COVID:19 pandemic, the recruitment process for this position has been placed ON HOLD. If you would still like to be considered for the role, you may apply to this position. When the status of the position returns to active and if your resume is selected for review, the recruiter will reach out. Thank you for considering CHOP. Our appreciation is sincere, knowing your talent is very valued.

Under minimal supervision, coordinates all clinical research activities within the scope of clinical research protocols.

Job Responsibilities 13;

Core 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
: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
:Must comply with federal, state, and sponsor policies

Related responsibilities

:Manage essential regulatory documents
:Register study on ClinicalTrial.gov
:Complete case report forms (paper and 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
:Facilitate study close out activities
:Coordinate research/project team meetings
:Collect, process and ship laboratory specimens
:Schedule subject visits and procedures
:Retain records/archive documents after study close out

Also may be responsible for any of the following:

:Manage study finances including sponsor invoicing and resolving study subject billing issues
:Develop advertisement materials
:Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
:Document investigational product (drug/device) accountability
:Self:monitor and self:audit responsibilities
:Develop informed consent document
:Maintain Clinical Trial.gov
:Develop Case Report Forms
:Assignments to include more complex studies

Job Responsibilities (Continued) 13;
Job Responsibilities (Continued) 13;
Required Licenses, Certifications, Registrations 13;
Required Education and Experience 13;

Required Education: Bachelors Degree in related field

Required Experience: Three (3) years of relevant clinical research coordination experience.

Preferred Education, Experience and Cert/Lic 13;

Preferred Education: Masters degree in a related field

Preferred Experience: Five (5) years of relevant clinical research coordination experience

Additional Technical Requirements 13;
:Excellent verbal and written communications skills
:Excellent time management skills
:Ability to collaborate with stakeholders at all levels
All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.

Childrens Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Childrens Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (


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