Clinical Research Coordinator II

PURPOSE AND SCOPE:

Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies in accordance with the study protocol and timelines.  Performs a variety of complex activities to appropriately compile, document and analyze clinical research data, using the subject’s medical record as source.  Negotiates differing priorities with multiple players whilst balancing a multiple number of tasks and timelines under a complex network of rules and regulations.

Ensures research studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP, ICH, and FDA guidelines.

Practices cost containment strategies while ensuring appropriate enrollment of subjects in studies.

 

PRINCIPAL DUTIES AND RESPONSIBILITIES:


* Assists with the determination of the guidelines for the collection of clinical data and coordinates and implements procedures and processes for data collection.


* Coordinates all aspects of study subject care from pre-screening through study completion as defined by the protocol and Principal Investigator (PI) delegation.


* Protect the rights and the well-being of subjects enrolled in studies.


* Ensures thorough, individualized, protocol-based study subject education on all study process requirements including but not limited to: informed consent, study participation obligations, appropriate use of investigational product, safety, privacy, rights and responsibilities.


* Develops processes for methodically monitoring the status of study subjects as they progress through the study’s timeline of activities.


* Regularly evaluates the study subjects’ condition and communicates/documents concerns to PI to ensure subject safety.


* Accurately documents study subject activities as outlined by the protocol.


* Maintains documents according to applicable HIPAA and regulatory requirements.


* Implements study-specific quality goals and practices.


* Acts as the point of contact or lead person in a facility/practice to oversee protocol compliance.


* Proactively addresses and acts upon adverse event or patient safety issues according to the appropriate procedure.


* Maintains study site environmental integrity including safe handling of biological specimens as well as study product procurement, administration, and storage.


* Participates as needed in study related, internal, or State/Federal surveys and audits.


* Maintains integrity of Fresenius Medical Care, practice and study-specific medical, administrative, and operational records.


* Troubleshoots protocol, and strategizes with all participants at every level of the study in order to assure quality study outcomes.


* Serves as primary point of contact between sponsor, Clinical Research Organization (CRO), PI and clinical staff.


* Adheres to SOP and GCP and all r...