Clinical Research Study Coordinator
Title: Clinical Research Study Coordinator
Position Type: Permanent, Full Time
Job Description: Responsible for the implementation and coordination of clinical research trials.
- Managing multiple clinical research study protocols ensuring ongoing adherence to each protocol as well as ICH/GCP, federal, state, and local guidelines.
- Maintain clinical research study regulatory files.
- Review and analyze data from medical charts for initial screening/identification of eligible subjects.
- Reviews protocol inclusion/exclusion criteria and confirms eligibility of subjects.
- Recruits and interviews prospective subjects for clinical studies. Familiarizes potential subjects with the details of the study through phone contacts and personal interviews.
- Maintain proper documentation in clinical research study subject's chart.
- Collection of required documentation and physician investigator signatures for Protocol
- Schedule research appointments, track progress and make reminder calls to retain participants in research studies.
- Maintain detailed database of subject information and participation, with particular sensitivity to issues of confidentiality and informed consent.
- Completes and submits continuing reviews of research as directed by the respective delays in re approval of study conduct in the respective site.
- May complete basic clinical procedures such as collect and process blood and other lab samples: perform vital signs, ECG's, pulmonary function tests and other study specific procedures.
- Immediate collection of all data pertaining to patient visits and immediate completion of paperwork to be sent to Sponsor Medical Director (via EDC or as directed by sponsor of study), Confirm all required data is collected and transferred to case report
- Complete all Case Report Forms (CRFs) before all monitoring visits during the study
- Attend to and resolve all queries in a timely manner.
- Communicate and coordinate with physicians, ancillary personnel, and hospital departments to
- Communicate with Sponsor and/or CRO to deliver and obtain proper study documents and information.
- Coordinate with physicians, hospital, coordinators schedules and other departments for scheduling the trials and visits
- Document and report of AE's and SAE's in a timely manner.
- Update and ensure that all device and/or drug accountability is current
- Receiving supplies, review inventory (devices, drugs)
- Additional responsibilities will depend on the current needs of the research group, and may include other projects as directed by the administrative team.
- Strong communication skills
- Excellent organizational skills
- Good interpersonal skills with patients and colleagues
- Creativity and resourcefulness
- Ability to work independently and with a team
- Strong critical thinking and good problem solving skills
- Strong conflict resolution skills
- Ability to work flexible hours
- Good computer skills + proficiency in Word, Excel
- Prior clinical research experience or a scientific and medical background is a plus but not necessary
College Degree preferred.
Similar to the working conditions found in most general administrative work areas with occasional requirement to travel short distances outside of the office to other physician investigator offices or, occasionally, also travel to Investigator or Site Initiation meetings in other states.
We are a clinical research company, with a primary focus on CNS medications for both adults and adolescents. We specialize in the following indications: Alzheimer's Disease, Major Depressive Disorder, Bi-Polar Disorder, and Schizophrenia.
Creve Coeur, MO
Sun, 17 Sep 2017 20:31:27 PDT