Summary:

ERG is the largest independent clinical research site services company focused on special populations and is the market leader in CNS. With 12 wholly owned clinical sites and 12 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. Our mission is to provide the highest quality execution of clinical trials in all clinical research phases aimed at helping sponsor companies to get their life saving or life enhancing drugs to market as quickly and safely as possible.

Under the direction of the Principal Investigator & Research Site Director, the Nurse Practitioner is responsible for assisting with the implementation of clinical trials, serving as a liaison between the investigative site and the sponsor. Responsible for accurately documenting all information obtained throughout the clinical research process.

Responsibilities:

• Always represents Endeavor Clinical Trials in a professional manner when interacting with sponsors, volunteers, outside venders and fellow employees.
• Participate in study planning process.
• Completes a company orientation program, prior to performing job responsibilities.
• Responsible for nursing care of study patients, according to protocol requirements and/or ECT standing orders.
• Develops, completes and maintains source documents.
• Recruits potential study subjects.
• Screens, consents, and conducts study procedures, as designated on the Delegation of Authority Log.
• Administers or coordinates the administration of investigational medication and follows subjects through the study period, per protocol.
• Conduct required assessments throughout the clinical trial assessment period.
• Responsible for maintaining and completing Case Report Forms in agreement with the source documentation and in accordance with study protocol.
• Assures drug and clinical supply accountability for assigned trials.
• Accompanies sponsors representatives during site visits and follows up, as needed.
• Accumulates all data and supplies for study start-up and study closure.
• Regularly attends training meetings, staff meetings, initiation meetings, study start-up meetings, and other meetings as assigned.
• Observes, documents, reports, and follows up on adverse events and serious adverse events.
• Conducts the informed consent process, per ECT Standard Operating Procedures.
• Ensures proper collection, processing, and shipment (if applicable) of laboratory specimens, in coordination with Research Assistants, if applicable.
• Follows up appropriately on all laboratory results.
• Maintains infection control safety standards when performing job responsibilities.
• Maintains study logs.
• Maintains study site relations.
• Performs procedures (i.e. vital signs, laboratory tests, etc.), as required by protocol and as allowed by level of licensure and/or training.
• Is on call to answer questions for other members of the ECT staff, study patients or medical staff, as necessary.
• Assists with quality assurance activities on studies, as assigned.
• Completes queries, as applicable.
• Obtains Principal Investigator signatures on necessary documents.
• Understands duties of Investigators as listed on the FDA form 1572.
• Maintain current training with SOP, DOP, IATA, CITI GCP, HIPAA and Research Topics.
• Perform duties as requested by the Medical Director, Principal Investigator and Research Site Director.

Skills and Qualifications:

• Must be an Advanced Practice Registered Nurse with a current license in the state in which the employee will be working.
• Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
• Must be capable of performing all clinical tasks relevant to licensure and/or training.
• Must be able to clearly communicate verbally with patients.
• Must have good interpersonal skills, demonstrated through interactions with patients, ECT staff, Sponsor representatives, etc.
• Excellent interpersonal and communication skills – interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral groups.
• Able to manage a staff of clinical professionals and create a productive, satisfying work environment.
• Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
• Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
• Must reflect the professional image of the company, upholding the company vision in actions and demeanor.