Job Description
Key Responsibilities:
- Manage and lead clinical trials, ensuring adherence to protocol requirements, GCP, ICH Guidelines, and SOPs.
- Perform and supervise clinical procedures such as venipuncture, capillary puncture, and other fluid collection activities, in line with the study protocol and regulatory guidelines.
- Prepare, process, and dispatch laboratory specimens as per the study protocol and IATA guidelines when applicable.
- Oversee the lifecycle of assigned clinical trials, including initiation, vendor coordination, subject recruitment, protocol training, scheduling, regulatory document collection, and adverse event management.
- Proactively address project risks and apply project management strategies to ensure quality and timely execution of clinical research.
- Develop and implement strategies for both research and administrative functions to manage protocols effectively and ensure smooth trial progression.
- Communicate clearly and professionally with study team members, leadership, participants, sponsors, CROs, and external vendors.
- Ensure accurate documentation practices per ALCOA-C principles, managing data transfer to sponsor or CRO systems, and resolving any data queries efficiently.
- Safeguard participant privacy and confidentiality, adhering to HIPAA regulations and ensuring all data is managed according to sponsor and protocol requirements.
- Monitor and escalate patient safety concerns, ensuring proper reporting and follow-up of adverse events, serious adverse events, and special-interest events as per the study protocol.
- Ensure that all data is entered into the sponsor’s data platform, resolving queries in accordance with the Clinical Trial Agreement.
- Delegate tasks effectively and ensure staff are trained and certified in necessary clinical procedures.
- Collect, review, and submit necessary regulatory documentation to sponsors and IRBs in compliance with GCP/ICH standards.
- Screen and evaluate potential clinical trial participants, conducting prescreening calls and in-person assessments.
- Implement recruitment strategies defined by the Clinical Research Team to ensure successful subject enrollment.
- Demonstrate a deep understanding of key clinical trial timelines, protocol requirements, required vendors, and the target patient population.
- Acquire a thorough understanding of the product development cycle and the significance of protocol design in achieving accurate and meaningful data points.
- Work collaboratively with the Clinical Research Team to develop and execute a quality control strategy, ensuring consistency and accuracy in data entry and trial activities.
- Perform clinical duties such as drug preparation and administration, ECG, fibroscan, phlebotomy, and lab processing in compliance with protocol requirements.
- Carry out additional duties as required to support the success of the clinical trial.
Must Have Education/Experience:
- Bachelor’s degree and 2 years relevant experience in the life science industry OR
- Associate’s degree with 4 years relevant experience in the life science industry OR
- High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year Clinical Research Coordinator experience
Required Licenses/Certifications:
- Phlebotomy if applicable and required by state law
- Intramuscular dose administration and preparation if applicable and required by state law
- Certified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role
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