General Summary

The MidLantic Urology is an established affiliate site of Solaris Health, offering clinical trials as an option to patients for over twenty years. Our goal is to provide patients with concierge navigation through all aspects of their high-level care with dedicated providers. MIU is looking to build on their foundation and experience to strengthen and expand their team, engaging more patients and providers in clinical research. 

To perform this job successfully, an individual must be able to perform each of the essential job functions satisfactorily. The requirements listed are representative of the knowledge, skills, minimum education, training, licensure, experience and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

Role & Responsibilities

· Reports directly to the Director of Clinical Research

· Adhere to clinical processes, procedures, programs, and corrective actions to maintain Quality Assurance at the site.

· Execute clinical trial activities in accordance with established research protocols and in compliance with all applicable laws, regulations, policies, and procedures

· Complete trainings in a timely manner and maintains working knowledge including but not limited to relevant FDA regulations, ICH-GCP guidelines, IATA, organizational SOPs, and assigned study protocols.

· Coordinate and perform duties for assigned clinical trials including but not limited to subject recruitment, participant visits, data collection, management and reporting of adverse events and serious adverse events

· Adhere to good documentation practices when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms.? 

· Assist with training staff (as delegated) in the conduct of clinical trials, protocol requirements, communication, and trial management skills 

· Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. 

· Ensure study timelines and recruitment expectations are met. 

· Order, receive, account for, and destroy supplies from local vendors and sponsors such as lab kits, ancillary supplies, and investigational products. 

· Investigates and resolves complaints, or refers unusual problems to Director of Clinical Research

· Perform duties of the department to ensure patient care, staff relations, and efficiency or service.

· Perform other position related duties as assigned 

Knowledge, Skills, Abilities

· Understanding of all aspects of biomedical research protocols, ensuring applicable regulations, and guidelines.

· Maintains patient confidentially.

· Excellent verbal and written communication skills.

· Skill in using computer programs and applications.

· Maintains current knowledge and awareness of organizational and regulatory standards, policies and procedures.

· Excellent organizational skills and attention to detail.

· Ability to build relationships with patients and display empathy and compassion to patients

· Skill in using computer programs and applications including Microsoft Office.

· Complies with HIPAA regulations for patient confidentiality.

· Complies with all health and safety policies of the organization.

Required Travel

· Local or national for Investigator Meetings as assigned

· Periodic local travel for Physician/staff meetings/trainings at other MIU offices

Physical Demands

Sit or stand for long periods of time

Lifting or carrying weight 

1-25lbs Frequently from 34% to 66%

26-50lbs Occasionally from 2% to 33%

50lbs +  

Certifications, Licensures or Registry Requirements

· BLS certification required, ACLS preferred

· RN or LPN licensure and certifications as required by State.

· GCP certification

Preferred: Clinical research certification (SoCRA, ACRP)

Education Requirements

· BSN or LPN from accredited Nursing Program required

Experience Requirements

· 2 or more years of experience as an RN or LPN (clinical research preferred)

· Nursing with previous oncology, emergency room, intensive care unit or telemetry experience

· Experience performing clinical assessments, including but not limited to EKGs, blood draw, injections, bladder instillations/catheter insertion, infusions.