Clinical Research Coordinator
2 weeks ago
Job Summary: The Clinical Research Assistant plays a crucial role in supporting clinical studies by ensuring compliance with protocols and maintaining high standards of patient interaction.
Key Responsibilities:
1) Adhere to all organizational policies and ethical guidelines.
2) Maintain strict confidentiality and compliance with regulatory standards.
3) Engage with study participants in a professional and courteous manner.
4) Gather comprehensive patient medical histories and current health conditions.
5) Facilitate the acquisition of Informed Consent Forms.
6) Manage the dispensing and accountability of study medications.
7) Collect and assess concomitant medications.
8) Review medical records to ensure compliance with study requirements.
9) Conduct assessments for Adverse Events (A/E) and Serious Adverse Events (SAE).
10) Perform EKGs, vital signs monitoring, and other protocol-specific tasks.
11) Collect, process, and ship biological samples including blood, urine, and tissue.
12) Assist in the upkeep of regulatory documentation for the site.
13) Ensure the accuracy of collected data.
14) Document temperature readings for investigational products stored on-site.
15) Interact with patients who have tested positive for COVID-19.
16) Oversee all necessary documentation, training, and timelines for assigned studies.
17) Fulfill all protocol requirements and timelines effectively.
Qualifications: To excel in this role, candidates must demonstrate the ability to perform essential duties competently. The following qualifications are essential:
Education and Experience:
1) A Bachelor's degree in Biology or a related discipline is required.
2) Proficiency in data collection and Microsoft Office is mandatory.
3) Willingness to travel between sites for clinical research activities is essential.
4) Previous research experience is preferred but not mandatory.
5) Certification as a Medical Assistant is advantageous.
6) Skills in phlebotomy, EKG, and other technical procedures as per protocol are preferred.
7) Familiarity with medical terminology is beneficial.
8) Ability to work independently with minimal supervision.
9) Strong problem-solving skills and adaptability are required.
10) Excellent verbal and written communication skills are a must.
11) Strong customer service skills for interaction with both internal and external stakeholders.
12) Proven ability to manage multiple tasks in a dynamic environment.
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