Clinical Research Assistant / Recruiter

Summary:

Clinical Research Assistant is responsible for conducting trials as per the GCP guidelines under the supervision of the Principal Investigator (PI) and Coordinator. In addition to providing and coordinating clinical care, this position has a central role in assuring subject safety, ongoing maintenance of informed consent, integrity of protocol implementation, accuracy of data collection, data recording and follow up.

Care received by research subjects is driven by study requirements and the collection of research data as well as clinical indications. This positions goal is to protect subjects participating in clinical trials, promote good clinical practices and professional management of clinical studies.

Essential Job Function:

1. Assisting trial Investigator in screening and review of potential study participants eligibility by reviewing medical records, discussions with the study subjects, physician, and nurses.

2. Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.

3. Ensure all data is accurately documented, such as patient vital signs, dispensation and administration of investigational product, adverse events, and concomitant medications. Available to subjects, subjects’ families, and investigators to answer questions at any time relating to specific clinical trial. Strive to advocate for their subjects while ensuring the integrity of the clinical research trial.

4. Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.

5. Direct the requisition, collection, labeling, storage, or shipment of specimens.

6. Participate in continuing education activities or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.

7. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

8. Perform specific protocol procedures such as interviewing subjects, taking vital signs, phlebotomy, and performing electrocardiograms.

9. Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.

10. Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.

11. Performs other related duties as needed.

12. .Other duties as assigned.

Knowledge, Skills and Abilities:

• Exceptional attention to detail with strong interpersonal skills.
• Excellent verbal & written communication and organizational skills.
• Ability to manage multiple tasks and prioritization
• Must be proficient in Excel, Microsoft Office, and other computer programs.

Supervisory Responsibilities:

None

Education:

• Certified Medical Assistant, associate’s degree in health care field and/or equivalent experience in the healthcare industry.
• Must have experience in Phlebotomy.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Work Location: In person