Sr. Clinical Research Coordinator

POSITION SUMMARY:

Under the general direction of the Principal Investigator (PI) or designee, the Senior Clinical Research Coordinator is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes coordination of regulatory activities and aspects of collection and management of data for complex research protocols related to treatment, ancillary services, and prevention practices.

Major Responsibilities:

Accountable for coordinating and obtaining consent of research participants for minimal risk studies in accordance with the IRB approved protocols and all applicable regulations including HIPAA

* Responsible for recruiting, screening, selecting, maintaining, and terminating study subjects for

multiple protocols

* Responsible for internal review/monitoring of clinical data for quality assurance purposes. Reports

findings

* Responsible for the smooth operation of all assigned studies on a day-to-day basis, interacting

with investigators, staff members, clinicians, sponsors, etc. to ensure project timelines and goals

are met

* Contribute independently to the development of preliminary designs for study related

documentation of data and collection tools, (e.g. questionnaires, treatment data and/or

therapeutic checklists)

* May Supervise the activities of research support staff. Assist with the selection, training, and

supervision of staff

* Prepare ongoing summary reports from various data sources, and collaborate with investigators

on data presentation, interpretation, and the writing of manuscripts for publication and grant

proposals

* Oversee all regulatory documentation, including local or central IRB and study data. Oversee

provision of data/support to study Investigators, sponsors and/or external monitors/auditors

* Identify and resolve issues with protocol compliance. Keep principal investigator and manager

aware of any issues regarding compliance

* Document and collect data and samples for research related procedures performed during

participant study visits. Ensure clinicians and/or PI accurately document their study activities

according to protocol

* Track and maintain study related information in the data management system within the required

timeframe

* Accountable for quality assurance reviews of study data

* Assist with financial /operational aspects of grant and contracts. Responsible for clinical research

billing review within the required timeframe.

* Present study status reports related to assigned research projects.

* Contribute independently to grant preparation, assessment of protocol feasibility, manuscript

writing, data presentations and Institutional Review Board (IRB) processes

* Provide detailed written summaries from literature searches and related sources to serve as a

resource for the study team and clinicians/PIs

* Monitor strict adherence to all study protocols, including all regulatory requirements adhering to

appropriate federal, local and institutional guidelines.

* Comply with all safety and infection control standards appropriate to this position

* Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices

* Perform other duties as required.

REQUIRED QUALIFICATIONS:

Requirements noted for CRC I plus:
• 5-7 years of related experience
• Demonstrated knowledge of quality management principles in a scientific or hospital setting

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