Clinical Study Coordinator Job Webster area,Texas USA,Healthcare

Clinical Study Coordinator

The role of the Clinical Study Coordinator is to ensure patient safety and wellbeing. The Clinical Study Coordinator will coordinate and perform study visits under the guidance and supervision of the principal investigator. This is an office-based position, working in the same location as the principal investigator or in the designated clinic.

To be successful in this role, the Clinical Study Coordinator should be able to perform critical patient evaluations, in addition to recognizing logistical problems and initiating appropriate solutions. Ideal candidates will be patient-focused, detail-oriented, have the ability to multitask, and be able to collaborate with various role players. The Clinical Study Coordinator must be able to work independently, be a team player, and proactively problem solve.

Qualifications

Bachelors Degree with related clinical experience
Experience working on clinical trials for a minimum of 2 years
Knowledge of FDA regulations and GCP
Accuracy, attention to detail, and ability to set priorities and meet deadlines
Basic Computer

Skills required:

Microsoft Office Suite, including Word PowerPoint, Excel
Other

Skills required:
- Excellent bedside manner and patient-centric focus
- Excellent time management and social skills
- Highly motivated with a phenomenal eye for detail

Duties and Responsibilities

Develop management systems and prepare for study initiation:

Assess study feasibility in terms of study's impact on-site resources, labor cost, cost by procedure, the potential for problems (such as serious AEs, noncompliance, the willingness of subjects to participate, protocol deviations, etc.)

Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility

Review with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol

Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity

Develop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarity

Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate.

Screen and enroll study subjects:

Review the study design and inclusion/exclusion criteria with the subject's primary physician

Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility

Review the protocol, informed consent form and follow-up procedures with potential study subjects

Ensure that the current approved informed consent is signed before subjects are screened and enrolled

Ensure that the randomization procedure is followed as per protocol guidelines

Document protocol exemptions and deviations.

Manage study-related activities, subject compliance and documentation:

Ensure adherence to protocol requirements

Schedule subjects for follow-up visits

Assist investigators in assessment of subject response to therapy

Review laboratory data, inform investigator of abnormal values and document

Report to primary care provider as appropriate

Assess and document subject compliance with medications and visits

Communicate with pharmacy staff to assure timely and accurate study drug distribution

Manage administration of investigational therapy

Maintain dispensing logs (if allowed)

Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies

Oversee specimen collection, storage and shipment

Attend study-related meetings as appropriate

Communicate regularly with the principal investigator, monitor (and others responsible for conduct of the research) about study-related issues.

Record data and study documentation:

Record data as directed using the appropriate media or platform

Follow procedures for access and security for electronic data entry

Review keyed data for accuracy, as needed

Send data to the data collection center on a timely basis

Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports

Correct and edit data as directed and as appropriate.

Monitor and report adverse events:

Assess, document and…