Clinical Research Coordinator - Registered Nurse - ON-SITE

* Together with Research Team and Research Review Committee, work with industry sponsor and physicians to identify appropriate protocols.
* Coordinate and facilitate site qualification visits.
* Assist in evaluation of all potential clinical research studies.
* Exhibit working knowledge of protocol(s), including objectives, rationale, and description of investigational product, inclusion/exclusion criteria, study visits and procedures, concomitant medications.
* Knowledgeable and confident to perform informed consent process; together with investigator, effectuate informed consent process.
* Communicates with sponsor to assure receipt of necessary study supplies (i.e., lab kits, CRFs, tools, investigational product, binders…), documents and maintains logs.
* Identifies study specific lab and ancillary procedures, contacts appropriate personnel within each department, facilitates training, certification, validation/calibration, and establishes workflow(s).
* Assemble and maintain source document binders assuring the most current version of informed consent is available.
* Prepare and distribute study related advertisements/recruitment materials (i.e., brochures, flyers, screening worksheets, physician-to-physician letters, Sound-card).
* Screen patients in appropriate departments and via data base query, if applicable, documents screening efforts and enters information as per protocol requirements.
* Maintain communication and visibility with investigators and support staff to promote and encourage patient enrollment.
* Enroll patients as per protocol.
* Schedule/order patient visits accurately: informed consent discussion, investigator visits, lab, and ancillary as per protocol.
* Promotes protocol compliance by being available at all patient visits.
* Ensures study documentation is complete and accurate; completes CRFs/EDC at time of enrollments and all subsequent visits within 48 hours of visit.
* Responds to queries/data clarifications adequately and within 5 days of receipt.
* Maintains minimum amount of queries/data clarifications.
* Prepare investigational product as per protocol requirements; together with investigator, dispense/administer investigational product, document and log appropriately according to SOP.
* Ensures investigator receives reviews and signs all lab and ancillary tests within 48 hours of receipt.
* Follow enrolled patient for duration of study and ensure follow-up visits, labs, ancillary testing is complete.
* Together with investigator, monitor for adverse events/serious adverse events.  Notify investigator immediately of any adverse event/serious adverse event.  Notify sponsor/IRB as per protocol requirements.  Assure accurate and timely documentation of any adverse event/serious adverse event.
* Inform patient of any changes in protocol, safety information, visit requirements by obtaining updated informed consent as required by sponsor.
* Coordinate monitor visits, ensure all source data is complete, accurate and signed and all CRFs/EDC are complete, all queries/data clarifications have been responded to.
* Available at all times during monitor visits for clarification and corrections.
* Knowledge of and works within guidelines of ICH/GCP and FDA regulations.
* Ensures all regulatory documents are filed in appropriate binder and correspondence/forms are submitted in timely manner; files regulatory documents within 5 days of receipt; maintains neat and orderly binders.
* Ensures safety reports are received, reviewed by investigator, signed/dated by investigator and filed appropriately.
* Prepares patient for investigator visit by obtaining medical history, concomitant medications, vital signs, questionnaires, lab/diagnostic results, and change in health status.
* Pushing and pulling, taking frequency and weight into consideration.
* Physical strength to lift objects, push carts, taking frequency and weight into consideration.
* Physical mobility, which includes movement from place to place on the job, taking distance and speed into account.
* Physical agility, which includes ability to maneuver body while in place.
* Dexterity of hands and fingers.
* Balance is maintained during climbing,…