Job description
Job description
Lead Clinical Research Coordinator (CRC)
Are you ready to take your career in Clinical Research to the next level? Our cardiology practice is seeking experienced Clinical Research Coordinator (CRC) to either assume or develop into a Lead CRC work in its Research Office. There you will be working as part of an experienced clinical research team. The practice and its physicians have a national reputation for excellence in cardiology including participation in conducting cutting-edge, clinical research.
Under the direction of the Clinical Research Director this position will assist in answering calls, scheduling appointments, screening subjects, taking medical histories, as well as organizing and maintaining subject files and regulatory documentation. You will also recruit and coordinate research subjects, as appropriate. The many and diverse administrative duties will require analysis skills, sound judgment, and a knowledge of study specific protocols. You will also require working with multiple software systems for record development and record keeping.
SPECIFIC DUTIES AND RESPONSIBILITIES:
- Managing office telephone systems, including answering calls and returning messages.
- Scheduling subjects’ appointment, procedures and maintaining communication to confirm future appointment consistent with protocol requirements.
- Documenting subjects' medical information, including medical history and visit information.
- Performing data entry tasks to document patient records within facility databases and maintaining subject files.
- Coordinating daily office activities, greeting subjects and checking patients in and out for their appointments.
- Maintaining data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data.
- Adhering to all Research Standard Operating Procedures, Good Clinical Practices, IATA Shipping Standards and Study Protocols.
- Coordinating research subjects and/or volunteers, as appropriate to specific study objectives and work scope.
- Ensuring scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials.
- Discussing study protocols with patients and assist in explanation of the Informed Consent Form (ICF) and verify the Informed Consent Form documentation.
- Providing copies of all written communication of their participation. (i.e. ICF’s)
- Ensuring subjects’ physician receives notification of subject’s participation in studies as requested by the patient.
- Meeting with subjects for study visits and maintain accessibility to discuss any questions/concerns regarding the study.
- Recording subjects' vital signs, documenting investigator' notes and changes in medical conditions.
- Taking blood, tissue and fluid samples, process and sending them in for laboratory analysis.
- Prepping exam rooms for research procedures and assisting investigators with patient care.
- Preparing and administering medications under the direction of supervising investigator.
- Dispensing study medication in a professional and accountable manner following protocol requirements.
- Preparing and administering medications under the direction of supervising investigator.
- Complete appropriate study medication accountability and logs as needed.
- Collecting, processing and shipping blood/urine specimens at the appropriate patient visits per the protocol.
- Performing ECGs and obtain vital signs of subject as required by the protocol.
- Performing other necessary testing, administering questionnaires, diaries and paperwork required by protocol.
- Assisting in the development of source documentation for studies.
- Maintaining all logs required by protocol.
- Ensuring that all non-serious and serious adverse events are properly documented and reported.
- Ensuring all laboratory results are given to investigator in a timely manner, and critical labs immediately reported to Investigator and the Clinical Research Administrator or Research Director immediately.
- Assisting in scheduling monitor visits and be available during such visits.
- Responding to all queries from the CRO or Sponsor in the timeframe laid out in the protocol.
- Ensuring the smooth and efficient day-to-day operation of research and data collection activities; acting as the primary administrative point of contact for internal research staff and as the principle operational liaison for other research organizations, funding agencies and regulating bodies.
- Coordinating the day-to-day activities of any technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
- Performing miscellaneous job-related duties as assigned.
- Monitoring investigational product temperature and reporting excursions.
EXPERIENCE REQUIREMENTS:
- Medical Assisting or Nursing Experience preferred.
- Previous Clinical Research Experience Preferred.
COMPETENCY REQUIREMENTS:
- Need to demonstrate consistent professional conduct and meticulous attention to detail.
- Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff and other health care professionals.
- Must be willing to sit for CCRC certification after 2 years’ experience.
- Able to attend 2-3 day out-of-town conferences as required.
- Planning/organizational skills.
- Ability to read, analyze and interpret information from professional journals, technical procedures or governmental regulations.
- Personal motivation.
- Project Management capabilities.
- Customer service skills.
- Able to effectively present information and respond to queries from physicians, staff and patients.
- Phlebotomy Skills.
- Understanding of Code of Federal Regulations for Human Subject.
- Knowledge of and when required certified in IATA regulations.
- Knowledge of EMR systems.
- Computer Competency including proficiency in Microsoft Word, Excel, Power Point, Clinical Conduct CTMS.
- Able to function effectively in a team setting.
- Understanding Phases I-IV drug development processes.
- ECG and any other technical skills related to the completion of a study visit as required by the protocol.
PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS
- Work is normally performed in a typical interior/office work environment.
- Travel required.
- Exposure to human bodily fluids.
- Laboratory processing procedures.
- Subject/Patient Care.
- Extensive Computer Use.
- Lifting up to 20 pounds and occasionally more than 20 pounds.
- Ability to drive and daily availability of an automobile.
Please reply by email, and attach your resume/CV. Please also include your desired salary and potential start date. Emails without these items cannot be considered.
Job Type: Full-time.
Salary: $18.00 - $23.00 per hour.
Benefits:
- 401(k).
- Dental insurance.
- Health insurance.
- Health savings account.
- Life insurance.
- Paid time off.
- Vision insurance.
Schedule:
- 8 hour shift.
- Monday to Friday.
Education:
- Associate (Preferred)
Experience:
- Clinical Trials: 1 year (Preferred)
- Clinical Research: 1 year (Preferred)
Work Location: One location.
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