POSITION SUMMARY:
We seek an experienced Clinical Research Coordinator /Research Nurse to collaborate with the Principal Investigator (PI) and the site's research team to conduct a double-blind study of an investigational treatment for Hypoglycemia. The CRC position is a 9-month, part-time, contractor position.
- Type of Position: Contract, Part-time, On-site
- Study Duration: 36 weeks
- Hours: 20 hours per week
- Location: Barcelona, Spain
- Reports to: Principal Investigator (PI) or designee
- Benefits: None
- Travel or Out-of-pocket Expenses: Not reimbursed
POSITION KEY ACCOUNTABILITIES:
Assists with the day-to-day project management coordination for research projects to
include personnel, facilities, and supplies in support of the research project's desired outcomes, budgets, and timeliness.
Assists in the comprehensive execution of the assigned protocol, compliant with research governing entities; prepares and maintains the following regulatory documents: monitoring, log/reports, a list of all patients who have signed an informed consent form and are screened or randomization into the study, a list of patients who are successfully randomized, and a list of those who do not meet the entry criteria.
Manage investigational product receipt and IP accountability, including clinical shipment release, drug dispensing log, and return shipment documentation as the protocol requires.
Prepares and maintains research files
Prepares for and participates in site monitoring visits; monitors visit phone calls and
recruitment discussions.
Ensures that all staff have received the proper training/attended the appropriate training courses.
Contact referring physicians as appropriate
Participates in subject consenting as directed by the PI (and in their presence).
Attend all scheduled study visits
Maintains confidential records, including source documents; ensures accuracy and integrity of data.
* Performs data entry and reviews data as directed.
* Responds to and resolves data queries
* Schedule and coordinate with the central clinical laboratory and pharmacy on the ordering, scheduling, completing, and reporting study-related procedures.
* Communicate with PI to ensure timely data review and patient labs.
* - Manages the handling of adverse events, compliance, and other participant-related issues.
Supports subject visits as directed by the PI
May interact with study volunteers by telephone and face-to-face (as appropriate) with the completion of study procedures according to protocol, including but not limited to obtaining medical history, demographics, vital signs, and concomitant medications.
May instruct (verbal and written) patient and caregiver on study procedures and visit schedules.
May support participants with compliance with Self-Monitoring of Blood Glucose and/or Continuous Glucose Monitoring (CGM)
May interact with the CGM vendor for support and/or supplies required as requested
May be required to complete blood draws.
Review reimbursement of subject travel and reimbursements.
Supports study safety reporting requirements.
Assists with response and preparation of audits.
Other duties as assigned by PI.
CERTIFICATIONS/SKILLS:
- Licensed to perform blood draws
- Excellent communication skills, both written and verbal
- Works well in a team environment
- Certificate of completion of GCP and CITI course on Human Subjects Research within the past year
- Working knowledge of MS Office (Word, Excel, and PowerPoint)
- Experience working as an independent contractor, preferred
- Experience with eClinical tools, including ePRO, EDC, EMR, etc.
MINIMUM EDUCATION/EXPERIENCE:
Required minimum educational qualification for the position
Nursing Degree
Required minimum amount of experience for the position
2 years of Clinical Research Coordinator experience
Knowledge of the regulations impacting the conduct of clinical trials, including but not limited to the Spanish Medicines and Medical Devices Agency (AEMPS), Ethics Committees for Research with Medicinal Products (CEIms), Spanish Data Protection Agency (AEPD), Ministry of Health and European Medicines Agency (EMA)Regulatory audit experience, preferred
Experience with regulatory audits preferred
Experience with interventional industry-sponsored clinical trials
Experience with clinical trials in the following therapeutic areas: endocrinology and/or metabolic disease trials,
ideal