Clinical Research Coordinator I

Montefiore Medical Center

Bronx, NY

JOB DETAILS
SALARY
$53,040–$66,300 Per Year
SKILLS
Clinical Assessment, Clinical Practices/Protocols, Clinical Research, Clinical Trial, Clinical Trial Management, Corrective Action, Data Collection, Data Entry, Data Quality, Drug Development, Electronic Medical Records, FDA (Food and Drug Administration), FDA Requirements, Genetics, Hospital, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Investigational New Drug (IND), Medical Billing, Military, National Institutes of Health (NIH), Neurology, Organizational Skills, Quality Assurance, Quality Management, Record Keeping, Recruiting Strategy, Regulations, Regulatory Requirements, Research Protocols, Site Initiation, Willing to Travel, Writing Skills
LOCATION
Bronx, NY
POSTED
3 days ago

City/State:

Bronx, New York

Grant Funded:

Yes

Department:

Neuro - Research/Clinical

Work Shift:

Day

Work Days:

MON-FRI

Scheduled Hours:

8:30 AM-5 PM

Scheduled Daily Hours:

7.5 HOURS

Pay Range:

$53,040.00-$66,300.00

Clinical Research Coordinator I will oversee multiple clinical trials, investigator-initiated studies, and quality improvement projects within the department of Neurology, serving as a point person for patients, their family members and the clinical study team. The position consists of working with various departments across the hospital, including forging new partnerships with departments to ensure completion of trial-related activities. The clinical research coordinator I will direct participants and study team members to adhere to the study protocol and rules and regulations as governed by regulatory bodies including Institutional Review Boards, NIH and the FDA.

Under general supervision duties will include:

  • Directing seamless flow of daily trial-related activities, recruitment and clinical assessments of the study subjects
  • Directing strict adherence to the study protocols, as well as sponsor, FDA and other regulatory authority requirements.
  • Designs and implements workflows for clinical trial, including reminders/updates to the clinical team
  • Coordinating team members to complete both clinical and non-clinical assessments per protocol. This includes developing workflow for patient care such as assigning secretaries to schedule patients, developing workflow with ancillary departments (such as radiology, advanced imaging, pathology, pharmacy), and assigning appropriate clinical team members such as doctors to complete clinical tasks such as reviewing adverse events versus assigning non-clinical team members to complete non clinical tasks such as administering questionnaires to a patient.
  • Executing IRB submissions (event reporting, study status change etc.)
  • Executing patient billing in multiple databases including the patient's electronic medical record.
  • Developing action plans for ensuring all study tasks are completed as required per the protocol and developing subsequent corrective action plans if any errors are made.
  • Leads and supports manuscript preparation, including drafting abstracts and manuscripts, coordinating co-author input, and preparing study data for presentation and submission to peer-reviewed journals.

The Clinical Research Coordinator I will be trained to be highly specialized in clinical trials assigned to them. The Clinical Research Coordinator I is expected to be able to manage clinical trial projects independently after sufficient training is completed

Essential Functions

  • Escalates issues related to clinical trial conduct to PI and senior research staff.
  • Assigns training to the PI and other research team members for protocol amendments, and any other study required training.
  • Screens and consents patients and ensures the scheduling and completion of assessments for ongoing study visits as dictated by the protocol
  • Collects required data and imaging and ensures data entry into EDCs/Databases and image upload to imaging portals.
  • Develops and executes multifaceted recruitment strategies by blending creative patient outreach with technical workflow integration and cross-departmental partnerships to optimize subject identification and enrollment.
  • Oversees the quality of data provided to sponsor, escalates quality issues to the site manager.
  • Maintains accurate records of study participants while safeguarding the confidentiality of subjects, as necessary.
  • Maintains essential documents per FDA, Regulatory bodies, and sponsor requirements in the Regulatory Binder. This includes preparation of essential documents for the assigned clinical study
  • Provides ready access to patient binders and regulatory binders to the PI, Sponsor and/or Regulatory Authorities for assigned clinical trials.
  • Coordinates and carries out monitoring visits and audits for assigned clinical trial.
  • Collaborates with appropriate institutional review board to ensure approval of the clinical trial (renewal), approval of study documents (renewal, modification, notification) and personnel.
  • Assists management with collection of updated essential documents and certifications for site personnel and sends these to sponsor as requested.
  • Participates in Site Initiation Visit.
  • Processes, packages, stores and ships clinical specimens as required by the protocol.
  • Responsible for device accountability, ordering and storage of investigational products and/or lab kits.
  • Performs other duties as assigned dependent on the nature of the clinical trial.

Qualifications

  • BS Required
  • OHS Annual Assessment Required
  • OHS Fit Test Required
  • CITI Good Clinical Practice Certification, CITI Research with Biomedical Drugs and Devices Certification, CITI Dangerous Goods and Biospecimen Handling Certification.

Experience in clinical research ,clinical trials and/or any medical related profession. Preferred

The position will be primarily based at the Moses campus, with occasional travel to other Montefiore locations as needed.

Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.

About the Company

M

Montefiore Medical Center

About Montefiore Medical Center

Commitment to Excellence

As the academic medical center and University Hospital for Albert Einstein College of Medicine, Montefiore Medical Center is nationally recognized for clinical excellence—breaking new ground in research, training the next generation of healthcare leaders, and delivering science-driven, patient-centered care.

Montefiore is ranked among the top hospitals nationally and regionally by U.S. News & World Report. For more than 100 years we have been innovating new treatments, new procedures and new approaches to patient care, producing stellar outcomes and raising the bar for medical centers in the region and around the world. As we build on this momentum, we continue to advance the practice of medicine and set the standard for excellence.

Enduring Mission and Distinguished History

The mission of Montefiore is to heal, to teach, to discover and to advance the health of the communities we serve.

From its beginning in 1884, as a facility for the care of patients with tuberculosis and other chronic illnesses, to the new millennium, Montefiore has been at the forefront of patient care, research and education and steadfast commitment to its community.

Our Services

We provide coordinated, compassionate and leading-edge care designed to reach people when and where they need it most. Through highly integrated teams of physicians, nurses, social workers, mental health professionals and other caregivers, we have created an innovative, seamless system of care focused around the patient.

Notable Centers of Excellence

At the intersection of Einstein science and Montefiore medicine is our commitment to scientific inquiry. This commitment has resulted in the creation of the Montefiore-Einstein Centers of Excellence in cancer care, cardiovascular services, transplantation and children’s health, where nationally recognized investigators and multidisciplinary clinical teams collaborate to develop and deliver advanced, innovative care.

Advanced Specialty and Surgical Care

We offer advanced, multidisciplinary care across specialties, delivering one standard of excellence for all. Our interventions are designed to help patients understand and manage their illness, advocate for their health, access the right treatments and receive the vital social support they need to flourish. On multiple fronts, Montefiore is developing more effective and less invasive approaches to complex problems from procedures to repair diseased hearts, protocols to treat complex cancers and medical devices designed to meet the needs of growing children.

Primary Care

With nearly 50 primary care locations throughout the New York metropolitan area, we are focusing on accessible, patient-centered primary and preventive care provided by leading physicians in the areas of family and internal medicine, pediatrics, obstetrics and gynecology, and a team of experts in nursing, health education, nutrition and pharmacy.

Providing Care Without Walls

Montefiore combines its deep commitment to the community with nationally-renowned expertise to reach people in locations easiest for them. Through Montefiore’s School Health Program (MSHP), Primary Care at Home programs, mobile medical and dental health vans and health education initiatives, Montefiore provides primary care services in non-traditional settings.

Through the formation of highly integrated teams of physicians, nurses, social workers, mental health professionals, care managers and other caregivers, we provide care around the patient, when and where they need it.

Research and Education

Montefiore's partnership with Einstein advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Together, the two institutions are among 38 academic medical centers nationwide to be awarded a prestigious Clinical and Translational Science Award (CTSA) by the National Institutes of Health.

The second-largest medical residency program in the country, with 1,251 residents and fellows across 89 programs, Montefiore provides the doctors of tomorrow a unique opportunity for education and training in one of the most diverse urban areas in the country — one where the population is global, the disease burden is high, and the need for quality care is great.

The partnership is further strengthened by the dual appointments of faculty and physicians across both organizations—enhancing synergies and collaborations for research, teaching and patient care.

Comprehensive Care Management

Since 1996, Montefiore has developed advanced models of care management to help patients, especially those with chronic diseases such as diabetes, heart failure and mental illness, achieve better health and improved wellbeing in a cost effective way. Montefiore goes beyond fragmented fee-for-service payments, assuming total responsibility for the quality and costs of care for some of our sickest patients.

Through CMO, Montefiore Care Management, we use a global prepayment or similar strategies to manage care for 200,000 individuals over the continuum, including hospital care, rehabilitation, outpatient care, professional services, home care, mental health counseling, community-based services, remote patient monitoring and many other programs.

Our leadership in coordinating care across multiple settings has earned us federal recognition from the Centers for Medicare and Medicaid Services as a Pioneer Accountable Care Organization. Montefiore's ACO is one of only 32 organizations in the nation, as well as the only one in New York State, to operate under this new model of providing Medicare beneficiaries with higher quality care, while reducing expenditures through enhanced care coordination.

Learn More

  • Mission, Vision and Values – Montefiore’s unique path of growth into the future and the clinical excellence and outstanding customer care that will get us there.
  • History and Milestones – Proud traditions guiding our mission and the moments that helped shape Montefiore into a premier academic medical center.
  • Commitment to the Community – Community health, education and neighborhood development.
  • Leadership – Executives and clinical chairs leading Montefiore’s advancements.
  • Physicians – Widely acclaimed medical professionals and specialists who provide our patients with the highest standards of care.
  • Nursing Staff – Highly competent and compassionate professionals committed to improving the health of their patients.
  • Ways to Give – Philanthropic opportunities and other ways to support Montefiore Medical Center.
COMPANY SIZE
10,000 employees or more
INDUSTRY
Healthcare Services
WEBSITE
http://www.montefiore.org/