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Clinical Research Assistant
1 month ago
SUMMARY: The Clinical Research Assistant who, under the direction and ongoing supervision of the Principal Investigator, assists in the daily function of clinical research programs.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Comply with all company policies, procedures, and conduct.
- Strictly adhere to confidentiality and compliance standards.
- Communicate effectively and courteously with study patients.
- Collect patient medical history and conditions.
- Obtain Informed Consent Forms.
- Study drug dispense and accountability.
- Collect and evaluate concomitant medication.
- Collect and evaluate medical records for compliance.
- Conduct A/E and SAE assessments.
- Perform EKG, vital signs and protocol specific procedures.
- Collect, process and ship blood, urine and tissue samples.
- Assist in maintaining office site regulatory files.
- Verify accuracy of data collected.
- Assist in documenting temperatures for IP stored on-site.
- Work directly with COVID-19 positive patients.
- Manage all required study startup documentation, training, and timelines on assigned study protocols.
- Meet all study protocol requirements and deadlines.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and EXPERIENCE:
- Bachelor’s degree in Biology or related field, required.
- Proficient in computer and data collection, Expert at Microsoft Office, required.
- Ability travel between site locations to conduct clinical research activities, required.
- Prior research experience preferred but not required.
- Certified Medical Assistant, preferred.
- 1-2 years Phlebotomy experience, required.
- EKG, and other technical skills as required per protocol, preferred.
- Prior knowledge of medical terminology.
- Ability to operate with limited direction.
- Effective Problem solver & Quick learner.
- Must possess excellent verbal and written communication skills.
- Excellent customer service skills with internal and external stakeholders.
- A proven ability to multi-task in a rapidly changing environment.
