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RESEARCH COORDINATOR

Employer
Geisinger
Location
Danville, PA
Posted Date
Sep 23, 2016

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Specialty
Research
Position Type
Permanent

Job Details

  Location: Research Center

Work Schedule: Days

Work Type: FULL TIME

Hiring Manager: Carroll Flansburg

 

 

JOB SUMMARY:

Responsible for supporting clinical and translational research as coordinator for multiple research studies and clinical trials in Genomic Medicine within the Geisinger Health System. Serves in an expanded role to assess the appropriateness of patients for research protocols. Under the direction of the Principal Investigator, performs assessments and collects data required for the research protocols.

Responsible for orchestration of all levels of study protocol from initial study invitation to study conclusion.

Responsible for the coordination and oversight of all Marketing and Public Relations efforts related to research and patient screening at their site.

Responsible for the development and management of patient recruitment efforts throughout the Geisinger Health System service area and other recruitment venues.

Responsible for organizing and participating in public education programs.

Reports to Principal Investigators for studies.

MAJOR DUTIES AND RESPONSIBILITIES:

A. Coordinates and implements clinical and translational research studies within the Genomic Medicine Institute.

*1. Responsible for implementing all Institutional Research Review Board (IRRB) changes in the GHS online submission system.

*2. Maintains current knowledge of federal regulations and guidelines of the Department of Health and Human Services, Food and Drug Administration (FDA), Good Clinical Practice Guidelines (GCP), and the International Conference on Harmonisation (ICH).

*3. Performs conduct of the research project, including but not limited to recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements.

*4. Develops and implements subject recruitment plans including interviewing subjects, collaborating with internal and external researchers, screening, and enrolling in accordance with GCP.

B. Patient responsibilities in the context of the study protocol.

*1. Monitors research patients in outpatient and inpatient settings for adverse experiences and compliance with study protocols.

2. Administers appropriate interviews, scales or other clinical measurements as needed in conjunction with PI.

3. Maintains log of study drug/study device for appropriate study management.

*4. Reviews medical records of patients, interviews patients and collaborates with investigators/clinicians to assess the appropriateness of patients for study enrollment.

5. Collects data for case report completion including source documentation.

*6. Screens patients both GHS and external for appropriateness criteria for study enrollment.

*7. Develops study-specific training tools and procedures to orient patient care staff about research interventions and protocols.

*8. Provides education to research community, department, investigators, study staff, and ancillary departments involved in the conduct of the study, as appropriate, to insure compliance with study protocol.

*9. Coordinates the services of all ancillary departments to ensure appropriate procedures are in place.

*10. Ensures timely and accurate submission of research data.

*11. Prepares lab specimens for shipment to study core lab. Monitors lab results and reports all findings to the principal investigator.

*12. Informs principal investigator of all relevant patient care issues and activities within research study.

*13. Collaborates with nursing staff and research personnel to incorporate all details of research protocol.

*14. Monitors study finances to comply with study-specific budget.
a. Aware of study budget requirements for participating clinical trials.
b. Insures appropriate billing charge documents are submitted.
c. Educates staff, as needed, to insure proper billing for study-related procedures in outpatient and inpatient areas.
d. Reviews monthly study-specific financial statements for accuracy and budget adherence.

C. Serves as a liaison.

*1. Provides education to subjects and family on specific research protocols, potential risks, benefits, and reporting of health events.

*2. Serves as a liaison between the principal investigator and the study sponsor for adapting a multi-center protocol to the specific local environment. Serves as site representative during Federally initiated study audits.

*3. Serves as a liaison between the principal investigator and Geisinger IRRB and outside regulatory agencies, such as FDA.

4. Represents GHS and principal investigator at regional, national, and international meetings.

5. Provides educational content regarding the rationale, importance and potential for involvement to patients in the community yearly.

D. Education.

1. Demonstrates a working knowledge of the electronic health record (EPIC) in relationship to research related activities.

*2. Attends Genomic Medicine Institute educational seminars and other genetic coursework to become familiar with genetics.

*3. Participates in continuing education to maintain current knowledge with federal, regional and local research regulations.

4. Attends and participates in seminars and research coordinator conferences.

*5. Attends mandatory education programs, documents and reports all necessary education/training
.
6. Attends cooperative group research base meetings for collaboration and updates regarding ongoing membership.

E. Performs other duties as assigned.

*Denotes essential job functions.

COMPETENCIES AND SKILLS:

Demonstrates strong working knowledge of medical terminology.

Demonstrates current knowledge of GCP and ICH guidelines, definitions and reporting requirements for adverse events, IRRB issues and guidelines, elements of informed consent, FDA codes and regulatory issues.

Demonstrates computer literacy in a MS Word, Excel, PowerPoint and ACCESS plus internet use.

Demonstrates excellent organizational and verbal and written communication skills. Must be able to effectively interact with all levels of staff, external sponsors, and research subjects.

Demonstrates ability to work independently with strong attention to detail.

Demonstrates ability to handle multiple projects and meet timelines in a dynamic workplace environment.

Demonstrates creativity and understanding of Public Relations and Marketing.

EDUCATION AND/OR EXPERIENCE:

Graduate of an accredited college/university with a Bachelor's degree in a scientific discipline or health related field required (Medical Technician, Nursing, Pharmacy, Physician Assistant). Coursework in biology and genetics preferred. Master's degree preferred.

Minimum three years dedicated research experience.

WORKING CONDITIONS/PHYSICAL DEMANDS:

Work is typically performed in an office environment. Independent travel to regional clinics and meetings may be required.

Work at the site of the research participant contact (clinic site, hospital units, emergency room) is required.

Work at the site of the patient screenings (clinic site, hospital units, community locations) is required.

The specific statements shown in each section of this description are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job.

 

 

About Geisinger

Geisinger Health System is an integrated health services organization widely recognized for its innovative use of the electronic health record and the development of innovative care delivery models such as ProvenHealth Navigator® and ProvenCare®. As one of the nation’s largest health service organizations, Geisinger serves more than 3 million residents throughout 45 counties in central, south-central and northeast Pennsylvania, and also in southern New Jersey with the addition of AtlantiCare, a National Malcolm Baldridge Award recipient. The physician-led system is comprised of approximately 30,000 employees, including nearly 1,600 employed physicians, 12 hospital campuses, two research centers and a 510,000-member health plan, all of which leverage an estimated $8.9 billion positive impact on the Pennsylvania economy. Geisinger has repeatedly garnered national accolades for integration, quality and service. In addition to fulfilling its patient care mission, Geisinger has a long-standing commitment to medical education, research and community service. For more information, visit www.geisinger.org, or follow the latest Geisinger news and more on Twitter and Facebook.

 

** Does not qualify for J-1 waiver.  We are an Affirmative Action, Equal Opportunity Employer Women and Minorities are Encouraged to Apply.  All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or their protected veteran status.

 

Company

Join an organization that’s leading healthcare change.

Geisinger is comprised of 13 hospital campuses, two research centers, a college of medicine and a nearly 600,000-member health plan serving more than three million residents in central, south-central and northeast Pennsylvania and beyond. We have approximately 26,500 employees, including over 1,700 employed physicians, all of whom share a commitment to quality healthcare.

You don’t have to put your life on hold to move healthcare forward. At Geisinger, you’ll engage with industry leaders to create new care delivery models and enjoy a work/life balance that gets you home in time for dinner. You’ll be there for your family, friends, and neighbors – making a difference at home and across the country.

Only at Geisinger

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