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Clinical/Translational Research Coord IV

Vanderbilt University Medical Center

This is a Full-time position in Nashville, TN posted August 18, 2021.

Clinical/Translational Research Coord IV
– 2101917**Job** : Research**Primary Location** : TN-Nashville-3322 West End Avenue**Organization** : VICC-Clinical Trials 200 104316**Shift:** : First Shift**Description****Job Summary**The Clinical Translational Research Coordinator is responsible for management and evaluation of research programs, assuring objectives are met and integrity and quality of the research is maintained.

Assures research is conducted in accordance with Good Clinical Practice Guidelines, federal/sponsor regulations and guidelines, Vanderbilt Policy and Procedure, research protocols and sponsor requirements.

Plans, implements and manages or provides oversight of the research from planning to completion, analysis and reporting.

Responsible for or provides oversight for communication with the sponsor, IRB, DSMB, regulatory agencies and other research related entities.

Functions as a departmental resource for research operations, a leader and role model, supervisor, consultant and educator.

Ensures the most effective operation through program development, performance monitoring, process improvement and coordination of processes across functions.**Department/Unit Summary:****Vanderbilt-Ingram Cancer Center** (VICC) is a leader in the prevention, diagnosis and treatment of cancer.

The centers world-renowned team of experts provides a integrated, personalized and patient-centered approach to cancer care, including treatment, research, support, education and outreach.

From a wide variety of wellness programs to a leading REACH for Survivorship Clinic, patients find support from diagnosis through survivorship.

VICC is a National Cancer Institute-designated Comprehensive Cancer Center, one of just two centers in Tennessee and 51 in the country to earn this highest distinction, and ranks in the top 10 nationwide for cancer research grant support.

Here is a link to our website
–**Position Shift:**+ First ShiftView how Vanderbilt Health employees celebrate the difference they make every day:**Discover Vanderbilt University Medical Center:**Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world.

It is a place where your expertise will be valued, your knowledge expanded and your abilities challenged.

It is a place where your diversity
– of culture, thinking, learning and leading
– is sought and celebrated.

It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday.

**Vanderbilt’s** mission is to advance health and wellness through preeminent programs in patient care, education, and research.**VUMC Recent Accomplishments**Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments: **US News & World Report:** #1 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr.

Children’s Hospital at Vanderbilt named as one of the Best Children’s Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked. **Healthcare’s Most Wired:** Among the nation’s 100 “most-wired” hospitals and health systems for its efforts in innovative medical technology. **Becker’s Hospital Review:** named as one of the “100 Great Hospitals in America”, in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs. **The Leapfrog Group:** One of only 10 children’s hospitals in the to be named at Leapfrog Top Hospital. **American Association for the Advancement of Science:** The School of Medicine has 112 elected fellows **Magnet Recognition Program:** Received our third consecutive Magnet designations. **National Academy of Medicine:** 22 members, elected by their peers in recognition of outstanding achievement **Human Rights Campaign Healthcare Equality Index: 6** **th** **year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.****Additional Key Elements/ Responsibilities:**+ Advanced knowledge and understanding of policies, procedures, and regulations governing human subject’s research and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research.

Compliantly, accurately and proficiently prepares, processes, and manages new research proposals, amendments, continuing review applications, adverse event reporting, budgets, and D&H accounts.+ Functions as a departmental resource, consultant and educator for the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations+ Functions as a departmental resource regarding the policies and procedures and requirements of Vanderbilt departments involved in the approval and proficient and compliant conduct of research (IRB, grants, contracts, finance, etc.)+ Expert knowledge and understanding of the management and implementation of clinical/translational research operations+ Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently.

(Able to identify when training is needed to safely and accurately perform or assess required procedures.

Prepares, provides and/or participates in needed training).

Problem solves when needed+ Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial.

Participates in or provides oversight of periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures.

Prepares reports and statistical analyses and participates in data quality assurance reviews+ Identifies and procures equipment and supplies needed to fulfill project requirements.

During protocol development, determines equipment and supply needs across the project, assures adequate budget and identifies suppliers+ Assists in identifying eligibility criteria for a protocol and assessing feasibility of recruiting and enrolling adequate populations locally and at participating sites.

Monitors recruitment across projects, implementing process improvement to assure projects are completed in a timely manner+ Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness.

Attends to query resolution in a timely manner.

Assists in determining data variables, in designing data dictionaries, and in developing data collection tools and databases and quality assurance processes.+ Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies.

In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies.

Coordinates activities and gathers information from a variety of sources to achieve stated outcomes.

Assures programs are compliant with reporting requirements.

Identifies the need for and provides oversight, education and training when appropriate+ Oversees the management of research samples.

Receives and tracks receipt and status of study specimens from multiple sites.

Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation.

Develops study specific standard operating procedures and tracking tools for specimen processing and handling.

Develops systems and procedures for the processing and management of research samples.

Ensures that all program staff have completed appropriate training as required+ Digests complex clinical/translational information to determine if documentation is accurate and, complete.

Understands standard of care versus research and its application in billing compliance.

Participates in budget and contract negotiation and facilitates interactions between sponsors and institutional departments.+ Responsible for project completion processes including timely study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing periodic quality checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation.

Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice+ Independently manages operational issues for large single and multi-center clinical/translational trials, including interacting with participating sites in the management of coordinating center activities, training, budget and invoicing, reporting to investigators, department administration and funding agencies+ Facilitates study and project related team meetings.

Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors+ Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures.

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