2 Lead Clinical Research Associate Remote jobs in whatjobs
Lead Clinical Research Associate (Remote)
Posted 13 days ago
Job Viewed
Job Description
Our client, a global biopharmaceutical company, is seeking an experienced and highly motivated Lead Clinical Research Associate (CRA) to join their expanding remote clinical operations team. In this crucial role, you will oversee and manage multiple clinical trial sites, ensuring adherence to Good Clinical Practice (GCP), study protocols, and regulatory requirements. You will play a vital part in the successful execution of clinical studies, from site initiation to close-out.
Key Responsibilities:
Key Responsibilities:
- Conduct pre-study, initiation, interim, and close-out visits for clinical trial sites.
- Monitor trial conduct to ensure adherence to protocol, regulatory requirements, and Good Clinical Practice (GCP).
- Verify the accuracy, completeness, and integrity of clinical data through source document verification.
- Train and mentor site staff on study-related procedures and documentation.
- Manage investigational product accountability and drug destruction.
- Ensure timely data entry and resolution of data queries.
- Build and maintain strong working relationships with investigators, study coordinators, and other site personnel.
- Identify and report adverse events and serious adverse events according to protocol and regulatory guidelines.
- Prepare and submit monitoring reports in a timely and accurate manner.
- Participate in protocol and study-related meetings as required.
- Ensure all site activities are well-documented and maintained in the trial master file (TMF).
- Contribute to the development and review of clinical study protocols and other study-related documents.
- Act as a primary point of contact for assigned sites and internal study teams.
- Provide guidance and oversight to junior CRAs, if applicable.
- Manage site-level recruitment and retention strategies.
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Lead Clinical Research Associate, Remote
Posted today
Job Viewed
Job Description
Our client, a prominent player in the pharmaceutical industry, is seeking a highly skilled and motivated Lead Clinical Research Associate (CRA) to join their fully remote team. This is a pivotal role responsible for overseeing and managing clinical trials, ensuring compliance with regulatory standards and ethical guidelines, and contributing to the development of innovative pharmaceuticals. As a Lead CRA, you will mentor junior CRAs, provide guidance on study conduct, and act as the primary point of contact for investigators, study sites, and internal stakeholders. Your responsibilities will include developing study protocols, creating case report forms (CRFs), monitoring patient data, and ensuring data accuracy and integrity. You will conduct site selection visits, initiation visits, interim monitoring visits, and close-out visits, ensuring that all trial activities are performed according to the approved protocol and Good Clinical Practice (GCP) guidelines. The ideal candidate will have a proven track record in clinical research, a thorough understanding of pharmaceutical development processes, and exceptional organizational and problem-solving skills. This role demands strong leadership qualities, excellent communication abilities, and the capacity to manage a complex caseload from a remote setting. You will play a critical role in advancing our client's pipeline of life-saving medications, working collaboratively with a dedicated team of professionals. This position requires a strategic mindset, attention to detail, and a passion for advancing healthcare through rigorous scientific research. You will be instrumental in ensuring the successful execution of clinical trials, contributing significantly to patient well-being and scientific advancement.
Responsibilities:
Responsibilities:
- Lead and manage multiple clinical trials from initiation to closure.
- Oversee and guide a team of Clinical Research Associates.
- Ensure compliance with FDA regulations, ICH guidelines, and GCP.
- Conduct site initiation, monitoring, and close-out visits.
- Train and mentor study site personnel on protocol requirements and data collection.
- Review and ensure the accuracy and completeness of clinical data.
- Liaise with investigators, site staff, and internal project teams.
- Identify and resolve site-level issues and deviations.
- Contribute to the development of clinical trial protocols and study documents.
- Manage trial timelines and budgets effectively.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related discipline.
- Minimum of 7 years of experience as a Clinical Research Associate.
- Extensive experience in pharmaceutical clinical trial management.
- In-depth knowledge of GCP, FDA regulations, and ICH guidelines.
- Proven leadership and team management skills.
- Excellent communication, interpersonal, and presentation skills.
- Strong problem-solving and decision-making abilities.
- Proficiency in clinical trial management software (CTMS) and EDC systems.
- Ability to work independently and manage a remote workload effectively.
This advertiser has chosen not to accept applicants from your region.
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