2 Clinical Research Associate Cra Pharmaceutical Remote jobs in whatjobs
Clinical Research Associate (CRA) - Pharmaceutical - Remote
Posted 4 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical innovator, is seeking a highly competent and experienced Clinical Research Associate (CRA) to join their expanding research and development team. This is a fully remote position, offering the flexibility to conduct site monitoring and essential study-related activities from anywhere. The successful candidate will play a critical role in ensuring the quality, integrity, and compliance of clinical trials, adhering to strict protocols and regulatory standards. You will be responsible for site management, data verification, and fostering strong relationships with investigators and site staff.
Responsibilities:
Responsibilities:
- Conduct pre-study, initiation, routine, and close-out visits to clinical trial sites according to study protocols and regulatory requirements.
- Monitor study conduct to ensure compliance with Good Clinical Practice (GCP), relevant regulations, and study-specific procedures.
- Verify the accuracy, completeness, and validity of clinical trial data by reviewing source documents and case report forms (CRFs).
- Ensure timely resolution of data queries and discrepancies in collaboration with site staff and data management teams.
- Manage communication and relationships with investigators and site personnel, providing training and support as needed.
- Oversee drug accountability and ensure proper storage and handling of investigational products at study sites.
- Prepare and submit comprehensive monitoring visit reports in a timely manner.
- Identify and report any deviations from study protocols, regulatory requirements, or standard operating procedures.
- Track site progress and ensure timely patient recruitment and retention.
- Assist in the selection and qualification of new clinical trial sites.
- Stay up-to-date with relevant therapeutic areas, protocols, and regulatory guidelines.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
- Minimum of 4 years of experience as a Clinical Research Associate, preferably in a pharmaceutical or contract research organization (CRO) setting.
- Thorough understanding of clinical trial processes, GCP guidelines, and regulatory requirements (e.g., FDA, EMA).
- Proven ability to effectively monitor clinical trial sites and manage relationships with investigators and site staff.
- Excellent organizational, time management, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to document findings clearly and concisely.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently, manage travel (if applicable, though this is remote), and prioritize tasks effectively in a remote environment.
- Attention to detail and commitment to data integrity and patient safety.
- Flexibility and adaptability to changing project needs and priorities.
This advertiser has chosen not to accept applicants from your region.
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Clinical Research Associate (CRA) - Pharmaceutical - Remote
Posted 22 days ago
Job Viewed
Job Description
Our client, a pioneering pharmaceutical company dedicated to advancing global health, is actively seeking a highly skilled and motivated Clinical Research Associate (CRA) to join their dynamic, fully remote clinical operations team. In this crucial role, you will be instrumental in ensuring the successful execution and oversight of clinical trials in compliance with Good Clinical Practice (GCP), regulatory requirements, and study protocols. You will be responsible for monitoring investigational sites, verifying data accuracy, ensuring patient safety, and maintaining essential study documentation. Key responsibilities include conducting site initiation visits, routine monitoring visits, and close-out visits; assessing protocol adherence; verifying source documentation against case report forms (CRFs); and ensuring investigational product accountability. The ideal candidate will possess excellent communication and interpersonal skills, enabling them to build strong relationships with investigators, site staff, and internal study teams. As a remote CRA, you will leverage technology to effectively manage your assigned sites, conduct virtual monitoring activities where appropriate, and travel to sites as required for essential in-person assessments. This is an outstanding opportunity to contribute to the development of life-changing therapies while enjoying the flexibility of a remote work arrangement. Your meticulous attention to detail and commitment to ethical research practices will be highly valued.
Responsibilities:
Responsibilities:
- Perform site selection, initiation, monitoring, and close-out visits in accordance with protocol and GCP guidelines.
- Verify the accuracy, completeness, and consistency of clinical data through source data verification.
- Ensure the safety and rights of study participants are protected at all times.
- Maintain investigational product accountability and ensure proper storage and handling.
- Verify compliance with the protocol, regulatory requirements, and standard operating procedures (SOPs).
- Prepare and present monitoring visit reports in a timely manner.
- Serve as the primary point of contact for study sites, addressing questions and resolving issues.
- Facilitate communication between study sites, the clinical study team, and other relevant parties.
- Ensure all study-related documentation is complete, accurate, and properly maintained.
- Participate in investigator meetings and training sessions.
- Bachelor's degree in a life science, nursing, or a related field; advanced degree is a plus.
- Minimum of 3-5 years of experience as a Clinical Research Associate (CRA) or equivalent role in the pharmaceutical or biotechnology industry.
- Thorough understanding of GCP, ICH guidelines, and relevant regulatory requirements.
- Demonstrated experience in clinical trial monitoring and site management.
- Excellent attention to detail and organizational skills.
- Strong written and verbal communication skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to travel to study sites as required.
- Self-motivated, with the ability to work independently and manage time effectively in a remote setting.
- Strong problem-solving abilities and a proactive approach.
This advertiser has chosen not to accept applicants from your region.
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