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CLINICAL RESEARCH COORDINATOR II

Envision Healthcare Fort Lauderdale, FL
  • Posted: August 02, 2019
  • Full-Time

Envision Physician Services is a multispecialty physician group and practice management company. Established in 1953, our organization provides anesthesia, emergency medicine, hospital medicine, radiology, primary/urgent care, surgical services, and women's and children's health services to hospitals and health systems nationwide. Sheridan Healthcare, EmCare, Reimbursement Technologies and Emergency Medical Associates have recently joined forces to form Envision Physician Services. As one organization, we now provide a greater scope of service than any other national physician group. Our collective experience from hundreds of local, customized engagements, culture of continuous lean process improvement, and team of experts in the business of healthcare enable us to better solve complex problems and consistently give healthcare organizations confidence in our execution. Our combined organization serves more than 780 healthcare facilities in 48 states and the District of Columbia.

If you are looking for a stable, fast-paced, growing company in the healthcare industry that is committed to innovation, excellence and integrity, then this may be a great next step in the advancement of your career.

We currently have a great opportunity for a Clinical Research Coordinator II opportunity at our corporate offices in Plantation. The Clinical Research Coordinator II is responsible for conducting pharmaceutical sponsored studies and overseeing the work of other clinical research coordinator I.
Conduct pharmaceutical sponsored studies in accordance with FDA regulations and Good Clinical Practice guidelines.

  • Enroll eligible subjects into research studies
  • Prepare CRF's
  • ow active protocols
  • Complete study related activities timely and accurately
  • Report relevant information to sponsor
  • Ensure the safety and well-being of study participants
  • Evaluate patients for protocol eligibility, monitor study patients' status, and compile clinical research data to submit to Sponsor
  • Review and conduct Informed Consent process with subjects
  • Screen patient charts to identify eligible study patients, and communicate with physician
  • Review and be familiar with all prospective protocol patients' charts to evaluate protocol eligibility, order necessary tests per protocol requirements
  • Register eligible patients on protocol with Sponsor and notify physician of treatment assignment
  • Monitor treatment to verify that proper drug dosages are given as per protocol requirements and that necessary lab work, x-rays, etc. are completed on schedule.
  • Handle all responsibilities of patient recruitment (call patients back in a timely manner from ad responses, hangs IRB approved posters in community areas, visit referring doctors for recruitment and health fairs etc.)
  • Schedule and conduct patient study visits in the office or patient telephone follow-up calls within time frame as per protocol.
  • Supervise daily operations of CRC at their site and report entity activity to the Project Manager daily.
  • Responsible for overseeing recruitment and screening activities to ensure enrollment goals are met and budget items are reported to the Project Manager for invoicing and collection
  • Ensure that all study Regulatory documents are filed properly and timely throughout duration of the trial
  • Quantify and prepare Site for CRC readiness for site visits (SQV, SIV, IMV).
  • Oversee CTMS (Study Manager) to make sure data is entered within 48 hrs. of patient visits.
  • Metric reporting monthly on subject visit activity and CRC Monthly Time Reports to Corporate Office
  • Oversee all other on site CRC activities
  • Ensure that monitoring visits are prepared for in advance for all active studies
  • Submit check requests for processing patient stipends, if applicable
  • Extract data from subject's charts and record it on source documents and CRF's for submission to Sponsor
  • Submit all required data in a timely manner, including preparing and submitting screening and enrollment logs for assigned protocols on the day specified by Sponsor
  • Obtain follow-up information on subject(s) according to protocol requirements.
  • Recognize and report AE's and SAE's to physicians, supervisor, IRB and to Sponsor as required by protocol
  • Prepare and submit additional reports: serious adverse events, screening logs etc.
  • Communicate with monitor/IRB/lab on assigned protocols
  • Participates in monitoring visits scheduled by sponsor for assigned protocols
  • Read, respond and file all information regarding assigned protocols, including regulatory documents, and Sponsor correspondence and data clarification requests.
  • Collect and schedule tests, patient visits and specimens per protocol requirements in an efficient manner
  • Arrange and package for shipment of samples, i.e. blood, slides, to appropriate labs institutions for analysis
  • Monitor supplies of study drug/study devices including expiration dates for distribution to study patients
  • Obtain, acknowledge and record shipment of study drugs
  • Monitor drug records/drug temperature log (ambient/freezer) and update drug accountability logs
  • Attend relevant conferences/meetings of the Sponsor pertaining to assigned protocol
  • Report any protocol violations to Manager, Investigator, and Director.
  • Other duties as assigned
  • Read and abide by the company's code of conduct, ethics statements, employee handbook(s), policies and procedures and other corporate mandates, including participation in mandatory training programs
  • Report any real or suspected violation of the corporate compliance program, company policies and procedures, harassment or other prohibited activities in accordance with the reporting policies of the company
  • Obtain clarification of policy whenever necessary and may use the resources available through the Compliance, Human Resources or Legal Department to do so
Qualifications:
  • Ability to oversee complex projects with strict protocols
  • Strong attention to detail
  • Ability to manage both patient and physician expectations
  • Strong problem solving ability
  • Takes initiative to ensure studies meet enrollment expectations and protocol adherence
  • Oversee workflow of others and distribute tasks
  • Good organizational skills
  • Communicate and work well in a team environment
  • Follow up in a timely manner on open items
  • Able to effectively prioritize work on a daily basis

Education/Experience:
  • Bachelor's Degree in healthcare or science and 4 or more years of related experience or an equivalent combination of education and experience

Computer Skills:

To perform this job successfully, an individual should have knowledge of:
  • Microsoft Office Suite

Certificates and Licenses:
  • Clinical Research Coordinator certification is preferred but not required

If you are ready to join an exciting, progressive company and have a strong work ethic, join our team of experts! We offer a highly competitive salary and a comprehensive benefits package.

Envision Physician Services uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.


Envision Physician Services is an Equal Opportunity Employer.

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ID (auto generated): 2019-20753
External Company Name: Envision Healthcare Systems
Street: 140 Sw 84Th Ave

Envision Healthcare

Address

Fort Lauderdale, FL
33388 USA

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