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Phlebotomist, Clinical Researcher

3 months ago

Ann Arbor, United States Topography Health Full time
Job DescriptionABOUT THE ROLE

Amazing opportunity to start a career in clinical research. Topography Health will train a certified Phlebotomist to be a research coordinator. We are seeking a dedicated and experienced healthcare professional to join our research team. The ideal candidate will coordinate and oversee clinical research studies, ensure compliance with regulatory requirements, and provide patient care within the framework of clinical trials. You will work closely with principal investigators, research coordinators, and other healthcare professionals to facilitate high-quality research and ensure the safety and well-being of study participants. In this role, we will train you to perform clinical research activities and protocol procedures in an exciting new environment, backed by a cutting-edge research architecture and a top-tier technology team, challenging the traditional paper-heavy methods of conducting studies. The position requires a strong desire to learn and grow rapidly, offering the opportunity to spearhead on-site efforts for Topography's partner healthcare groups. Performance will be evaluated based on provider success, patient experience, protocol management and adherence, and data quality. A successful candidate will have the ability to handle multiple tasks simultaneously and solve problems independently on a daily basis is essential. Leading with empathy for patients and a commitment to expanding access to clinical research in communities across the country is crucial.

KEY RESPONSIBILITIES

Act as the study coordinator to execute trials conducted within physician practices, including visit preparation, follow-up activities, supply and inventory management, and third-party vendor management.

Coordinate and manage clinical research studies from initiation to completion, including patient recruitment, enrollment, and follow-up.

Conduct patient recruitment and enrollment of eligible patients, ensuring thorough screening and informed consent processes.

Lead patient study visits, which may include but is not limited to clinical and lab procedures such as ECG, phlebotomy, vital signs, body measurements, and laboratory processing.

Ensure protocol adherence and high data integrity, providing high-quality source data capture and documentation, including case report forms, source documents, and study logs.

Support study start-up and planning activities, including pre-study visits (PSVs), site initiation visits (SIVs), and IRB submission and correspondence.

Facilitate monitoring visits (IMVs) and sponsor correspondence, managing the follow-up process and ensuring compliance with regulatory requirements, institutional policies, and Good Clinical Practice (GCP) guidelines.

Manage the dispensation and accountability of investigational products, ensuring accurate tracking and documentation.

Monitor and document patient responses to treatments, managing adverse events, tracking, and follow-up as per protocol requirements.

Conduct data entry into case report forms/electronic data capture (CRF/EDC) systems and resolve queries in a timely manner.

Conduct Quality Control (QC) activities, including routine checks during and following study visits to ensure meticulous accuracy in documentation.

Provide training and support to research staff, mentoring junior research staff, and ensuring adherence to study protocols and standard operating procedures (SOPs).

Participate in the development and implementation of study protocols and quality assurance processes, utilizing and improving Topography's proprietary tool set.

Assist in the preparation for audits and inspections by regulatory agencies, supporting study close-out activities (COVs), and managing protocol deviation tracking, reporting, and reconciliation

Any other duties assigned by the manager will be performed as required.

MINIMUM QUALIFICATIONS

3+ years of experience as Phlebotomist

Certified Medical Assistant OR Certified LPN

PREFERRED QUALIFICATIONS

Previous research experience