Posted: Tuesday, September 12, 2017 12:51 AM
Employment Status:AF : Active : Regular : Full Time
Job Summary 13;
Under moderate supervision, coordinates all clinical research activities within the scope of clinical research protocols.
Job Responsibilities 13;
The CRC I is expected to perform all CRC Core responsibilities (as applicable):
: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.
Also may be responsible for any of the following:
: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 visits
: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 13;
Required Education and Experience 13;
Required Education:: AA/AAS in a related field
Required Experience: 3+ year(s) relevant clinical research experience
Preferred Education, Experience and Cert/Lic 13;
Preferred Education: BA/BS in a related field
Preferred Experience: 2+ year(s) relevant clinical research experience
Experience with literature reviews, scientific writing helpful.
Must have good organizational skills and time management.
Must be able to work collaboratively in a team.
General understanding of statistics and computer logic necessary. Any experience with website development also helpful.
Additional Technical Requirements 13;
Requires effective writing and communication, work as part of a team, ability to multitask
• Location: South Jersey
• Post ID: 44518647 southjersey