Job Responsibilities:

• Adhere to Research SOP’s

• Adhere to Good Clinical Practices and the study protocols

• Process clinical data, including receipt, entry, verification, or filing of information.

• Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems.

• Develop project-specific data management plans that address areas such as reporting, or transfer of data, database locks, and workflow processes.

• Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.

• Evaluate processes and technologies and suggest revisions to increase productivity and efficiency.

• Write work instruction manuals, data capture guidelines, or standard operating procedures.

• Track the flow of work forms, including in-house data flow or electronic forms transfer.

• Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.

• Ensure the filing and maintenance of all regulatory documents.

• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

• Discuss study protocols with patients and verify the informed consent documentation

• Provide patient with written communication of their participation (i.e. copy of the signed informed consent)

• Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder

• Schedule monitor visits and set up for monitoring

• Work on questionnaires/diaries per protocol

• Ensure that non-serious and serious adverse events are properly documented and reported

• Screen all laboratory results when received and follow protocol procedure regarding abnormal results

• Ensure patient's referring physician receives notification of patient’s participation in studies as requested by the patient

• Meet with patient for each visit and maintain accessibility to discuss any questions/concerns regarding the study

• Perform ECGs and obtain vital signs of patients

• Schedule all patient research visits and procedures consistent with protocol requirements

Job Type: Full-time
Benefits:

• Medical (Health, Dental, Vision)

• 401k Matching

• Paid Time Off

Education:

• Bachelor’s degree in Natural Sciences or Applied Life Sciences or Health Sciences or Healthcare or Healthcare Administration (Required)

Experience:

• Clinical Trials: 1 year (Preferred)