A licensed PA or APN to work as a clinical research coordinator / sub-investigator who manages clinical trial study conduct on a day to day basis under the oversight of the Principal Investigator. The clinical research coordinator (CRC) conducts study visits as per the trial protocol and completes procedures per site SOPs. The CRC collects data from study subjects, records the data, and reports it to the sponsor or clinical research organization (CRO). The CRC works with the principal investigator to coordinate and manage medical evaluation and care for the subject during study conduct. The CRC also handles administrative aspects of study conduct including document management, recruitment, regulatory, and sponsor/ CRO correspondence.
At Amici Clinical Research, the CRC coordinates subject-visit related activities, while collaborating and supporting other roles and activities to ensure highest levels of integrity, quality and business performance. In addition, depending upon the individual, management of other CRCs and staff will be expected.
The clinical research coordinator is overseen by the Principal Investigator.
Specific duties may differ depending on each trial's parameters.
Receive training on the procedures and components of a trial.
Directly perform end-to-end subject-visit related activities
- Prepare for visits
- Perform informed consent process
- Perform subject procedures and visit tasks
- Complete source documents / work checklists, obtaining signoffs where specified
- Dispense investigational product
- Perform lab work (draws, prep, packaging, shipping)
- Enter data into sponsor EDC (data capture system)
- Various in-between visit activities such as answering sponsor queries
Perform other ongoing study work
- Report SAEs and other reporting deliverables, including to IRB, CRO, Sponsors
- Manage and/or escalate issues
- Support ongoing regulatory work
- Support Site Monitoring (by sponsor/CRO)
- Support Site Regulatory Inspection / Sponsor or CRO Audit
- Support maintenance of equipment calibration / asset records
- Closeout study
- Perform recruitment which may include:
- Create recruitment strategies and plans
- Perform recruitment and scheduling
- Support new study evaluation:
- Complete sponsor study/site evaluation forms
- Establish recruitment feasibility
Support study startup activities which may include:
- Prepare sponsor regulatory package/forms
- Receive study equipment
- Create source documents and filing locations
- Create e-source and visit configuration
- Create study FMEA and mitigations
- Support staff training
- Complete regulatory documents
Collaborate with central functions as needed
Perform other job duties as assigned
- PA/APN licensed in the state of NJ required.
- Prefer 2 years of Clinical Research Coordinator experience.
- The clinical research coordinator must possess excellent clerical skills, good interpersonal skills, and must be able to provide accurate documentation of his or her work.
- The clinical research coordinator should have proficiency at clinical skills including phlebotomy, vital sign measurements, and performing ECGs under the preceptorship of a Sub-investigator. Previous hands-on experience and knowledge of such clinical skills is preferred.
Job Type: Full-time
- Employee Assistance Program
- Flexible Spending Account
- Paid Time Off
We have an extensive program for keeping our team and our patients safe, including controls such as PPE, questionnaires, temp checking, hybrid virtual visits, etc.
- Investigator Site Clinical Trials Coordination: 1 year (Required)
- New Jersey APN or PA (Required)
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