What are the responsibilities and job description for the Clinical Research Coordinator - 238289 position at Medix™?
The Clinical Research Coordinator works with and under the direct supervision of the Principal Investigator. Meticulous and curious by nature, the Clinical Research Coordinator supports, facilitates and coordinates the daily clinical trial activities and is instrumental in assuring the proper conduct of multiple trials. As the cornerstone of clinical research, the Clinical Research Coordinator is responsible for facilitating protocol related guidance regarding compliance, personnel and other relevant aspects of trials at multiple research sites, medical institutions, CRO’s and Sponsors.
Clinical Research Coordinator must have
- 2 years of Clinical Research experience as a Research Assistant or an equivalent combination experience and abilities related to the conduct of clinical trials.
- Demonstrated interpersonal, written and verbal communication skills and excellent phone etiquette skills.
- Experience in industry sponsored clinical trials.
- Experience interpreting medical charts and obtaining data from medical records.
- Experience in medical assessments and patient interaction.
- Experience with laboratory procedures and values for proper recording and reporting to the Principal Investigator.
- Understanding of FDA, IRB and other regulatory regulations regarding clinical trials.
Preferred Qualifications
- Certification as a Clinical Research Associate or Coordinator.
- Bachelor’s degree in a natural science (i.e. Biology, Chemistry, BSN, ect.)
- Marketing and PR experience.
- Current certifications in Good Clinical Practice (GCP), the National Institute of Health (NIH) and Shipping of Blood Specimens, and Blood borne Pathogens (IATA).
- Experience in CKD, Dialysis or Renal Transplantation
- Bilingual in English and Spanish
Duties will include:
Administrative Duties (may include, but not limited to):
- Enters data into the study specific EDC and site CTMS in a timely manner.
- Manages Research Assistant study vendor, EDC, site CTMS and other study related data reporting entry.
- Maintains and manages all trial specific source documentation.
- Manages the collection, recording, reporting and storage of study related data, study binders, investigational product and study equipment.
- Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
- Communicates and works directly with the CRO and Sponsor representatives during pre-study, IMV and site closure; adhering to site specific standard operating procedures, local and federal regulations.
- Supplies weekly and monthly reports to supervisors including but not limited to: pipeline status, current trial status, screening activities, enrollment expectations vs. actual enrollment status, study timelines and other study or site-specific needs.
Clinical Duties (may include, but not limited to):
- Comprehension of each study protocol.
- Completion of all required training required per protocol during the pre-study, enrollment and maintenance and closeout phases.
- Regular networking with local medical staff regarding study information, marketing and PR efforts related to study awareness and subject referrals.
- Assists the PI in subject recruitment, screening eligibility, informed consent and subject retention.
- Conducts all study visits as required per protocol.
- Responsible for the collection and reporting of subject data, AE/SAE’s within accepted guidelines.
