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Clinical Research Support Specialist
2 months ago
Company Overview
Charter Research is a dynamic and rapidly expanding clinical research organization dedicated to the advancement of medical science. We focus on delivering exceptional experiences for our participants while implementing effective recruitment strategies for our sponsors. Our team-oriented culture is essential to our mission of discovering innovative therapies.
Position Summary
The Clinical Research Support Specialist plays a crucial role in facilitating the daily operations of clinical trials aimed at evaluating the safety and efficacy of new medications. This position involves collaborating closely with the Principal Investigator (PI) and Clinical Research Coordinators (CRCs) to ensure the successful execution of clinical research studies. Team members are expected to adhere to Good Clinical Practice (GCP) guidelines while maintaining accurate and thorough documentation.
Key Responsibilities
- Thoroughly comprehend all assigned studies by reviewing protocols, participating in investigator meetings, and coordinating with the PI and CRC.
- Assist in the execution of clinical research studies, ensuring strict adherence to study protocols, including patient visit requirements, informed consent processes, and laboratory procedures.
- Educate patients and their families about the clinical trials process and the specifics of their participation.
- Support the PI and CRC in evaluating potential patient eligibility and oversee the enrollment process, ensuring informed consent is obtained and documented appropriately.
- Coordinate and perform patient visit procedures, including blood draws, vital sign assessments, and ECGs, as directed.
- Ensure compliance with clinical trial protocols and GCP standards during all study visit procedures.
- Maintain availability of necessary study supplies for conducting clinical trial visits and procedures.
- Communicate any clinical trial issues to the PI and CRC, facilitating documentation and communication with sponsors and vendor agencies as required.
- Keep all source documentation current and compliant with ALCOA-C standards.
- Assist in maintaining communication with sponsors and/or Clinical Research Associates (CRAs) to support study monitoring and data management.
- Address all monitor and sponsor inquiries promptly, as directed by the PI and CRC.
- Track patient enrollment status and provide timely updates to patients regarding their participation.
- Prepare for and/or participate in quality assurance audits conducted by sponsors or regulatory agencies as directed by the PI and CRC.
- Perform additional duties as assigned by the PI and CRC to ensure the efficient operation of clinical trials.
Qualifications
- Strong interpersonal and customer service skills.
- Familiarity with medical terminology.
- Exceptional organizational abilities and attention to detail.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively within a team.
- Capacity to manage multiple tasks simultaneously and adapt to changing responsibilities.
- High level of integrity and ability to maintain confidentiality in accordance with HIPAA regulations.
- Phlebotomy skills are advantageous.
Educational Background
- Bachelor's degree preferred, ideally in psychology, biology, health sciences, or a related discipline.
- Relevant medical certifications such as Medical Assistant (MA), Certified Phlebotomy Technician (CPT), or Licensed Practical Nurse (LPN) are a plus.
Experience
- 1-3 years of relevant experience is required.
Physical Requirements
- Ability to sit for extended periods while working on a computer.
- Ability to stand, bend, and reach for prolonged periods.
- Physical capability to assist patients as needed, including lifting up to 30 pounds occasionally.
