Clinical Research Coordinator I

Eastern Nephrology Associates•Wilmington, NC

21h•$22 - $26•Onsite

About The Position

To serve as a clinical research coordinator during the conduct of clinical research at the investigative site. Works under the direct supervision of the Principal Investigator. Coordinates all activities for the implementation and conduct of clinical trials. Responsible for the collection, accuracy, and validity of data for assigned clinical studies in accordance with the study protocol and study timelines. Responsible for the collection and submission of regulatory documents, performance of study specific procedures and regulatory reporting requirements as instructed by the Principal Investigator and governed by Good Clinical Practice and International Council for Harmonization. Works under the supervision of the Principal Investigator to conceptually apply research protocol to clinical setting to allow for accurate and timely completion of all duties. Maintains all appropriate documentation associated with the assigned clinical study. Ensures studies are conducted according to established organization policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice, International Council for Harmonization and Food and Drug Administration guidelines. This position is designated as an on-site, patient-facing role. In-office presence is an essential function due to the need for real-time collaboration with providers, direct interaction with patients and caregivers, and secure handling of health data in compliance with HIPAA.

Requirements

2 to 4 years of healthcare experience or 2 to 4 years as a Clinical Research Assistant, or any combination of the two.
Certified Medical Assistant Required.
Skilled in the use of personal computers and related software applications to include Microsoft Office Applications and email.
Participates in 24-hour emergency on-call rotation
Valid drivers’ license and reliable transportation to allow individual to provide support to offsite locations, as necessary.
Ability to provide a minimum of a 4 week notice in the event resignation is tendered.
Excellent record maintenance skills.
Ability to communicate effectively both orally and written.
Proactive individual with the ability to be a self-starter
Ability to function independently and enjoy a fast paced, challenging, changing environment; possesses the energy and commitment to help the organization move forward.
Maintain a positive and professional attitude in all aspects of work from patient care to interaction with co-workers and physicians.
Demonstrated human relations and effective communication skills are required.
Ability to understand the ethics of confidentiality and the ability to maintain confidentiality of sensitive information.
Maintains confidentiality of patients and their medical information.
Maintains confidentiality of research activities as required by study sponsor confidentiality agreements and mandates.
Must be able to meet deadlines for multiple concurrent projects.
Ability to understand and follow policies, procedures and direction.
Ability to foster a cooperative work environment. Possess willingness to accept orders and to perform repetitive tasks.
Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Ability to make evaluative judgments.
Ability to function well while involved in multiple task assignments.
Ability to concentrate on details and deal with constant interruption.
Skill in organizing resources and establishing priorities.
Ability to travel to attend off-site meetings as necessary and directed.
Ability to delegate tasks to clinical research assistants and clinical research administrative assistants as applicable.
Ability to ensure studies are conducted according to established organization policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice, International Council for Harmonization and Food and Drug Administration guidelines.