Clinical Research Coordinator (3245)

US Heart & Vascular•Social Circle, GA

41d•Onsite

About The Position

US Heart and Vascular is seeking a Certified Clinical Research Coordinator to join our team at NSC Cardiology in Johns Creek, GA. This role involves coordinating and overseeing clinical operations of medical research projects, including assessing, planning, implementing, and evaluating subject care. The coordinator will establish organizational policies and procedures for clinical research and carry out research under the general supervision of physicians responsible for clinical trials.

Requirements

Successful completion/documentation of research training course and BLS certification required.
High degree of empathy for subjects
Ability to work independently.
Demonstrated supervisory and project management skills
Strong problem-solving abilities
Understands OSHA guidelines for handling hazardous biological and chemical materials

Nice To Haves

CCRC preferred

Responsibilities

Obtain and review medical records for potential research subjects; maintain medical records of research subjects that include documentation of laboratory test results and progress of research study subjects, following guidelines set forth by the protocol sponsors.
Recruit clinical study subjects; schedule appointments and interviews, and evaluate potential subjects.
Instruct potential research subjects, responsible family members, and physicians, nurse practitioners, physician assistants, nursing staff, and ancillary staff involved in care of subjects on aspects of the subject’s care, available research studies, treatments, and side effects.
Educate subjects concerning diagnosis and treatment plan and explain informed consent procedures, including HIPAA authorizations, to research study subjects and obtain subjects’ written consent.
Evaluate and develop subject education materials and give subjects and/or family members instruction on drug administration and other medical information.
Perform physical assessments and monitor subjects' progress during clinical trials and notify principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects.
Perform initial interview during each subject visit and plan appropriate care under direction of a physician, nurse practitioner, or physician assistant.
Provide emotional and educational support to research subjects and serve as liaison between them and the investigators.
Coordinate research activities, including scheduling laboratory tests, radiology testing, and/or exams for study subjects.
Complete case report forms for each study participant and document medical data in subject study chart.
Perform and/or oversee a variety of clinical duties that may include EKGs, blood smears, and processing of blood serum, urine, and chemistries and recording the results in the subject study chart.
Communicate all lab results to PI and medical staff.
Prepare and/or oversee the preparation of biological specimens for shipment to reference laboratory and centrifugation of hazardous biological and chemical materials.
Notify research study subjects of laboratory test results.
Assess and document compliance of research subjects.
Participate with other research staff in assessing, planning, implementing, and evaluating the success of research studies with other healthcare providers.
Coordinate research activities with related medical departments clinic and hospital.
Attend staff meetings/conferences as part of a team of physicians, pharmacy, nurses, other ancillary areas, and research staff.
Discuss current medical treatments, medications, and therapies with medical company representatives and relay this information to medical staff, offering suggestions on the use of new treatments, medications, and therapies.
Act as principal investigator's representative as appropriate. This may include communicating with private and pharmaceutical company personnel and the clinical research unit.
Maintain subject database information.
May assist in preparing for publication.
Work with analysts and assist with queries related to data to evaluate the significance of compiled data.
Assist investigators with data collection, review of literature, methodology, and writing of abstracts.
Investigate literature for general and specific references of interest to the research protocols and conduct library research as needed.
Review potential protocols to evaluate their suitability for study.
Prepare project approval forms necessary for submission to appropriate committees.
Develop written informed consent forms for new protocols in accordance with FDA regulations.
Prepare project approval forms necessary for submission to appropriate committees.
Assist physician/principal investigator in writing manuscripts for publication and/or presentation of materials at conferences.
Attend research meetings and conferences as required.
Provide orientation, information, training/cross-training, and assistance for new/existing nursing personnel, research assistants, and medical staff to the research activities.
Participate in staff meetings and in-service education of nursing and medical staff.
Maintain adequate inventory of research supplies necessary for research activities.
Maintain exam rooms and laboratory.
Perform other related duties as assigned.
Valid driver’s license, vehicle, and cell phone are required.