Clinical Research Coordinator - MF - 8:00am-5:00pm
Northeast Georgia Health System
Location: Gainesville, Georgia
Internal Number: R8585
Research & Research Administration
8 Hr Morning - Afternoon
Northeast Georgia Health System is rooted in a foundation of improving the health of our communities.
About the Role:
The Clinical Research Coordinator (CRC) supports the research program and maintains appropriate and accurate documentation of patient/study participant evaluation data. The Clinical Research Coordinator coordinates strategies for recruitment of study participants, enrolls participants, and manages data collection and reporting for institutionally approved research studies. The position ensures the requirements are met for subject enrollment and compliance (from entry through follow-up), investigator participation data report submission, and audits. In addition, the CRC ensures that research protocols are evaluated and approved by appropriate internal and external oversight bodies including, but not limited to, the National Cancer Institute (NCI), the Food and Drug Administration (FDA), IRB of Record or Central IRB (if applicable), Research Committee, and appropriate principal investigators. The CRC serves as a resource regarding clinical research and compliance for investigators, nurses, pharmacists, pathologists, radiologists and other health care personnel.
Minimum Job Qualifications
Licensure or other certifications: None required; current licensure as LPN/RN or Certified Clinical Research Coordinator (CCRC) preferred
Educational Requirements: Associates Degree
Minimum Experience: Previous experience in clinical trials, data management and a strong understanding of oncology are preferred. Must have experience in working with patients either through direct patient care or in the conduct of clinical research. Experience working with a variety of contacts within and outside of the workplace. Ability to manage group processes and build effective working relationships.
Other: Graduate of an accredited school of nursing. Eligibility requirements for certification: twelve (12) months full-time case management experience supervised by a certified case manager, or twenty-four (24) months full-time case management experience not supervised by a certified case manager.
Preferred Job Qualifications
Preferred Licensure or other certifications: Current licensure as LPN/RN or Certified Clinical Research Coordinator (CCRC)
Preferred Educational Requirements: A college degree in a health or a science related field (Biology, Microbiology, Social Sciences). Bachelors degree, preferred.
Job Specific and Unique Knowledge, Skills and Abilities
Demonstrated knowledge of medical and clinical terminology.
Demonstrated organizational skills, attention to detail, and strong interpersonal and communication skills.
Self-directed, resourceful, and uses a high degree of independent judgment and discretion.
Must possess previous PC-based work processing and spread sheet knowledge.Proficiency required in the use of Windows, Word, Excel, etc.
Competency with Windows environment, various databases, EMR/EHR systems, and various other CTMS software applications.
Use of business office machines and basic lab equipment such as computers, FAX machines, laser printers, centrifuge, hot plates, and pipettes.
Remains current in knowledge and skills related to conducting clinical research.
Essential Tasks and Responsibilities
Working with the physician, exercises good clinical skills to evaluate apatient's eligibility for clinical trial enrollment.Ensures that only eligible participants are registered for studies and appropriate randomization procedures are followed.
Ensures the quality and completeness of all study material, data, and clinical research forms submitted are in compliance with institutional and regulatory guidelines and with the sponsor's protocol requirements.
Responsible for the submission of all pathology specimens and imaging results within time frames required by the institution and the sponsor.
Ensures that all study medication is maintained, transported/ dispensed, destroyed (if applicable), administered, in compliance with protocol / sponsor guidelines, NCI/ federal regulations, Good Clinical Practice,and institutional policies and procedures. Confirms that the pharmacy maintains an accurate protocol Drug Accountability Record Form (DARF) if applicable.
Documents study related patient activity in the patient's research medical record and research data base in a concise, objective, and accurate manner.
Communicates with the study patient and the physician to ensure protocol compliance, and provides assistance in treatment and symptom management as indicated by protocol guidelines.
Maintains effective methods for monitoring protocol compliance and resolves compliance issues in a timely and effective manner as determined by the protocol, as well as by departmental guidelines and metrics.
Ensures accurate and timely maintenance of the CTMS, research database, and statistics related to protocols and patients.
Develops, implements and evaluates effective data and time management systems both on a personal and team level that assist in meeting data submission deadlines of the department and research sponsor.
Continually identifies opportunities for improvement or enhancement in clinical research processes based on personal experience and information acquired from other programs, professional associates, and review of literature.
Develops, implements, and maintains office organization and filing systems that foster teamwork and communication.
Completes Adverse Events (AE) Reports timely and submits them in compliance with the FDA, sponsor,and institutional policy.
Maintains high quality-control standards as determined by both internal quality control documentation and research sponsor or external evaluations (reports and audits).
Ensures accuracy of data submitted by research support staff,and provides instruction/communication to them in regards to department policies and procedures and protocol / sponsor guidelines and requirements.
Ensures investigator, physician, staff nurse, and other appropriate individuals' compliance with following appropriate trial protocols.
Consistently develops and implements new case finding strategies for clinical trials studies (i.e., use of pathology reports, surgery schedules, physician appointment schedules, tumor registries, advertisement, public relations, events, communications).
Provides support, ongoing education and updates to physicians, nurses and other health professionals regarding protocol activities, including subject eligibility criteria, updates on new studies, amendments and closures.
Consistently identifies potential barriers to study participant and physician participation in cancer control studies and/or clinical trials; develops and implements methods to alleviate those barriers.
Routinely identifies strategies and methods, and participates in community events that facilitate investigator interest and public awareness of the department's clinical research program.
Consistently assumes a proactive, positive approach when working with physician and office staffthrough routine communication, phone calls, correspondence, etc., and serve as a knowledgeable resource.
Assumes lead role in helping coordinate department team projects that foster compliance and reinforce positive relationships between research staff and investigators / office staff.
Coordinates and participates in monitor visits and research base audits to ensure a smooth and positive process and outcome.
Attends appropriate research base and sponsor meetings throughout the year as approved.
Coordinates/contributes to professional presentations for internal and external audiences in the field of clinical research.
Weight Lifted: Up to 20 lbs, Occasionally 0-30% of time
Weight Carried: Up to 20 lbs, Occasionally 0-30% of time
Working at NGHS means being part of something special: a team invested in you as a person, an employee, and in helping you reach your goals.
NGHS: Opportunities start here.
Northeast Georgia Health System is an Equal Opportunity Employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, protected veteran status, genetic information, or any other legally protected classification or status.
Northeast Georgia Health System (NGHS) is a not-for-profit community health system dedicated to improving the health and quality of life of the people of Northeast Georgia. Through the services of a medical staff of more than 600 physicians, the residents of northeast Georgia enjoy access to the state's finest and most comprehensive medical services. It is our mission to improve the health of our community in all we do.