5,116 Lead Cra jobs in the United States
Lead Clinical Research Associate (CRA)
97201 Portland, Oregon
$120000 Annually
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Posted 5 days ago
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Job Description
Our client, a pioneering pharmaceutical company, is seeking a highly experienced Lead Clinical Research Associate (CRA) to manage and oversee clinical trial sites in the **Portland, Oregon, US** region. This senior role requires a comprehensive understanding of clinical trial processes, regulatory requirements, and site management best practices. You will be responsible for ensuring the quality, integrity, and compliance of clinical trial data collected at assigned investigational sites. Your expertise will be vital in building strong relationships with investigators and site staff, facilitating efficient trial conduct, and ensuring the safety of study participants.
Key responsibilities include:
The ideal candidate will possess a Bachelor's degree in a life science, nursing, or a related field. A minimum of 5-7 years of experience as a Clinical Research Associate is required, with demonstrated experience in a lead or supervisory capacity. Thorough knowledge of ICH GCP guidelines and federal regulations governing clinical trials is essential. Proven ability to manage multiple sites and complex protocols is a must. Excellent communication, interpersonal, and organizational skills are critical. The ability to travel up to 70% of the time within the **Portland, Oregon, US** area and surrounding regions is required. Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS) is necessary. We are looking for a dedicated and meticulous professional with a strong commitment to ethical research practices and patient safety. This role offers a significant opportunity to contribute to groundbreaking pharmaceutical research and development.
Key responsibilities include:
- Conducting pre-study visits, site initiation visits, interim monitoring visits, and close-out visits according to protocol and regulatory requirements.
- Monitoring study conduct to ensure compliance with the investigational plan, SOPs, GCP, and all applicable regulations.
- Verifying the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
- Managing study site activities, including ensuring timely subject recruitment and retention.
- Training and mentoring site staff on study-specific procedures, data collection, and regulatory compliance.
- Serving as the primary point of contact between the sponsor and the investigational site.
- Identifying and resolving site-related issues and discrepancies in a timely manner.
- Ensuring that study supplies are managed appropriately and that investigational product is accounted for.
- Preparing detailed monitoring visit reports and communicating findings and action items to the site and study team.
- Contributing to the development and review of study-related documents, such as protocols and informed consent forms.
The ideal candidate will possess a Bachelor's degree in a life science, nursing, or a related field. A minimum of 5-7 years of experience as a Clinical Research Associate is required, with demonstrated experience in a lead or supervisory capacity. Thorough knowledge of ICH GCP guidelines and federal regulations governing clinical trials is essential. Proven ability to manage multiple sites and complex protocols is a must. Excellent communication, interpersonal, and organizational skills are critical. The ability to travel up to 70% of the time within the **Portland, Oregon, US** area and surrounding regions is required. Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS) is necessary. We are looking for a dedicated and meticulous professional with a strong commitment to ethical research practices and patient safety. This role offers a significant opportunity to contribute to groundbreaking pharmaceutical research and development.
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0
Lead Clinical Research Associate (CRA)
10001 New York, New York
$125000 Annually
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Posted 5 days ago
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Job Description
Our client is seeking a highly experienced Lead Clinical Research Associate (CRA) to join our innovative pharmaceutical team based in **New York City, New York, US**. This pivotal role involves overseeing and managing all aspects of clinical trial site activities to ensure compliance with protocols, GCP, and regulatory requirements. You will be responsible for training, mentoring, and supervising a team of CRAs, ensuring the successful execution of multiple clinical studies. Key responsibilities include developing and implementing clinical trial monitoring strategies, performing site initiation, interim, and close-out visits, and ensuring data accuracy and integrity. You will serve as the primary point of contact for clinical sites, fostering strong relationships with investigators and site staff. The Lead CRA will also be involved in site selection, budget negotiation, and ensuring timely recruitment of study participants. Proactive identification and resolution of site issues and risks are paramount. You will prepare and present study progress reports, contribute to the development of study documentation, and collaborate closely with internal teams, including data management, biostatistics, and regulatory affairs. The ideal candidate possesses exceptional leadership, organizational, and communication skills, with a deep understanding of clinical trial operations within the pharmaceutical industry. A proven track record of successfully managing clinical trials and leading CRA teams is essential. Strong knowledge of ICH-GCP guidelines and relevant regulatory requirements is mandatory. Minimum of 7 years of experience in clinical research, with at least 3 years in a Lead CRA or supervisory role. A Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field is required; an advanced degree is a plus. This is an excellent opportunity for a seasoned professional to take on a leadership role in clinical research at a prestigious location in **New York City, New York, US**, contributing to the development of life-changing therapeutics.
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1
Lead Clinical Research Associate (CRA)
35801 Huntsville, Alabama
$110000 Annually
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Posted 6 days ago
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Job Description
Our client is looking for an experienced and dedicated Lead Clinical Research Associate (CRA) to manage and oversee clinical trial activities in the pharmaceutical sector. This critical role, based in Huntsville, Alabama, US , will ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols. You will be responsible for site selection, initiation, monitoring, and close-out visits, as well as building strong relationships with investigators and site staff. This position requires a deep understanding of clinical trial processes, excellent organizational skills, and the ability to lead and mentor junior CRAs.
Key responsibilities include:
The ideal candidate will hold a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline. A minimum of 7 years of experience as a Clinical Research Associate, with at least 2 years in a Lead CRA or senior monitoring role, is required. Comprehensive knowledge of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA) is essential. Demonstrated experience in therapeutic areas such as oncology, cardiology, or infectious diseases is highly desirable. Excellent communication, interpersonal, and problem-solving skills are crucial. The ability to travel frequently to investigative sites is mandatory. This is a unique opportunity to contribute to groundbreaking pharmaceutical research within our client's facilities in Huntsville, Alabama, US .
Key responsibilities include:
- Conducting pre-study, initiation, interim monitoring, and close-out visits in accordance with clinical trial protocols and GCP.
- Ensuring the quality and integrity of clinical trial data through meticulous source data verification and query resolution.
- Training and mentoring investigative site staff on study procedures, protocol requirements, and regulatory compliance.
- Identifying, evaluating, and recommending potential clinical trial sites.
- Managing site performance and proactively identifying and addressing potential issues to ensure timely study milestones.
- Serving as the primary point of contact between the sponsor and the investigative sites.
- Preparing and submitting essential study documents and regulatory filings.
- Participating in the development and review of clinical trial protocols, informed consent forms, and other study-related documents.
- Contributing to the development and implementation of risk-based monitoring strategies.
- Ensuring all study-related activities are documented accurately and maintained in the trial master file.
- Collaborating with cross-functional teams, including clinical operations, data management, and regulatory affairs.
- Leading team meetings and providing updates on site performance and overall study progress.
The ideal candidate will hold a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline. A minimum of 7 years of experience as a Clinical Research Associate, with at least 2 years in a Lead CRA or senior monitoring role, is required. Comprehensive knowledge of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA) is essential. Demonstrated experience in therapeutic areas such as oncology, cardiology, or infectious diseases is highly desirable. Excellent communication, interpersonal, and problem-solving skills are crucial. The ability to travel frequently to investigative sites is mandatory. This is a unique opportunity to contribute to groundbreaking pharmaceutical research within our client's facilities in Huntsville, Alabama, US .
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2
Lead Clinical Research Associate (CRA)
60601 Chicago, Illinois
$100000 Annually
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Posted 7 days ago
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Job Description
Our client, a globally recognized pharmaceutical leader, is seeking a highly experienced and dedicated Lead Clinical Research Associate (CRA) to oversee clinical trial operations in **Chicago, Illinois, US**. This pivotal role will be instrumental in ensuring the successful execution of clinical studies, adhering to all regulatory requirements and company standards. The Lead CRA will provide guidance and support to a team of CRAs, fostering an environment of excellence and compliance.
Responsibilities:
Qualifications:
This is an exceptional opportunity to advance your career in a challenging and rewarding environment, working on cutting-edge pharmaceutical research.
Responsibilities:
- Lead and manage a team of CRAs, providing mentorship, training, and performance management.
- Oversee the initiation, monitoring, and closure of clinical trial sites.
- Ensure compliance with Good Clinical Practice (GCP), FDA regulations, and other applicable guidelines.
- Conduct site visits (pre-study, initiation, routine monitoring, and close-out) as needed and provide detailed trip reports.
- Verify accuracy and completeness of clinical data through source document verification.
- Manage investigational product accountability at clinical sites.
- Serve as the primary point of contact for study sites, addressing queries and resolving issues promptly.
- Prepare and present study progress reports to project management and stakeholders.
- Contribute to the development of study protocols, informed consent forms, and other essential study documents.
- Ensure timely and accurate submission of safety reports and other regulatory documents.
- Participate in investigator meetings and other study-related events.
- Collaborate with cross-functional teams, including data management, biostatistics, and regulatory affairs.
Qualifications:
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 5-7 years of experience as a Clinical Research Associate, with at least 2 years in a lead or supervisory role.
- Extensive knowledge of ICH-GCP guidelines, FDA regulations, and drug development process.
- Proven experience in managing multiple clinical trials simultaneously across various therapeutic areas.
- Excellent leadership, team management, and interpersonal skills.
- Strong organizational and time management abilities, with exceptional attention to detail.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Excellent written and verbal communication skills.
- Ability to travel up to 50% of the time, including potential overnight stays.
This is an exceptional opportunity to advance your career in a challenging and rewarding environment, working on cutting-edge pharmaceutical research.
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3
Lead Clinical Research Associate (CRA)
32830 Orlando, Florida
$100000 Annually
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Posted 7 days ago
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Job Description
Our client, a cutting-edge pharmaceutical company focused on developing life-saving therapies, is seeking an experienced Lead Clinical Research Associate (CRA) to oversee and manage clinical trial sites. This is a remote position that offers the flexibility to work from anywhere within the US, contributing significantly to the advancement of novel drug development.
As a Lead CRA, you will be responsible for monitoring the progress of clinical trials at various investigative sites, ensuring that trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and applicable regulations (e.g., GCP, ICH guidelines). You will provide training and guidance to site staff, troubleshoot issues that arise during trial conduct, and ensure the quality and integrity of the data collected. This role involves regular site visits (both remotely and potentially in-person as needed), assessing site compliance, and facilitating communication between the investigative sites and the clinical operations team.
The ideal candidate will possess a Bachelor's degree in a life science, nursing, or a related field, with at least 5-7 years of experience as a CRA, including significant experience with site monitoring and data management. A strong understanding of clinical trial processes, regulatory requirements, and therapeutic areas is essential. Excellent communication, interpersonal, and organizational skills are a must, along with the ability to work independently and manage multiple priorities effectively. Proficiency in clinical trial management software and electronic data capture (EDC) systems is required. This is a fantastic opportunity to join a highly motivated team and play a pivotal role in bringing innovative pharmaceutical products to market. While primarily remote, some domestic travel may be required for on-site monitoring or investigator meetings.
Location: Orlando, Florida, US
As a Lead CRA, you will be responsible for monitoring the progress of clinical trials at various investigative sites, ensuring that trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and applicable regulations (e.g., GCP, ICH guidelines). You will provide training and guidance to site staff, troubleshoot issues that arise during trial conduct, and ensure the quality and integrity of the data collected. This role involves regular site visits (both remotely and potentially in-person as needed), assessing site compliance, and facilitating communication between the investigative sites and the clinical operations team.
The ideal candidate will possess a Bachelor's degree in a life science, nursing, or a related field, with at least 5-7 years of experience as a CRA, including significant experience with site monitoring and data management. A strong understanding of clinical trial processes, regulatory requirements, and therapeutic areas is essential. Excellent communication, interpersonal, and organizational skills are a must, along with the ability to work independently and manage multiple priorities effectively. Proficiency in clinical trial management software and electronic data capture (EDC) systems is required. This is a fantastic opportunity to join a highly motivated team and play a pivotal role in bringing innovative pharmaceutical products to market. While primarily remote, some domestic travel may be required for on-site monitoring or investigator meetings.
Location: Orlando, Florida, US
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4
Lead Clinical Research Associate (CRA)
89101 Sunrise Manor, Nevada
$110000 Annually
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Posted 7 days ago
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Job Description
Our client, a rapidly growing pharmaceutical company, is seeking an experienced Lead Clinical Research Associate (CRA) to oversee clinical trial activities in **Las Vegas, Nevada, US**. This critical role involves managing site operations, ensuring compliance with regulatory standards (GCP, FDA, ICH), and driving the successful execution of clinical studies. You will be responsible for training and mentoring junior CRAs, building strong relationships with study sites, and ensuring the integrity and accuracy of clinical trial data. The ideal candidate possesses a strong background in clinical research, exceptional organizational skills, and a proven ability to lead and motivate teams.
Key responsibilities include:
Required qualifications:
Key responsibilities include:
- Overseeing and managing multiple clinical trial sites to ensure adherence to protocols, GCP, and regulatory requirements.
- Conducting site initiation, monitoring, and close-out visits; ensuring all required documentation is accurate and complete.
- Training and mentoring site staff and junior CRAs on study protocols, procedures, and regulatory compliance.
- Developing and implementing strategies to improve site performance and patient recruitment.
- Serving as the primary point of contact between the sponsor, study sites, and other stakeholders.
- Reviewing and resolving data discrepancies and ensuring data quality and integrity.
- Identifying and mitigating study-related risks and implementing corrective action plans as needed.
- Preparing comprehensive monitoring reports and contributing to study progress updates.
- Ensuring timely submission of regulatory documents and trial supplies.
- Participating in protocol development and study design discussions.
Required qualifications:
- Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
- Minimum of 5-7 years of experience as a Clinical Research Associate, with demonstrated leadership experience.
- In-depth knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes.
- Proven experience in site management, patient recruitment strategies, and data quality assurance.
- Excellent verbal and written communication skills, with the ability to build rapport with diverse stakeholders.
- Strong analytical and problem-solving abilities, with meticulous attention to detail.
- Ability to travel frequently (up to 60%) to various study sites.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Certification as a CRA (e.g., ACRP, SoCRA) is highly desirable.
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5
Lead Clinical Research Associate (CRA)
23451 Virginia Beach, Virginia
$110000 Annually
WhatJobs
Posted 7 days ago
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Job Description
Our client, a prominent leader in pharmaceutical innovation, is seeking an exceptional Lead Clinical Research Associate (CRA) to oversee and manage critical clinical trial activities. This role demands a seasoned professional with extensive experience in conducting clinical trials from initiation to closeout, ensuring compliance with all regulatory requirements and study protocols. You will be responsible for site selection, initiation, monitoring, and closeout visits, as well as managing investigator relationships and ensuring data integrity and patient safety. The Lead CRA will mentor and guide junior CRAs, contributing to their professional development and ensuring adherence to standard operating procedures. This position requires a deep understanding of ICH-GCP guidelines and FDA regulations. You will work closely with internal teams, including data management, regulatory affairs, and project management, to ensure the smooth execution of clinical studies. Essential duties include developing study-specific monitoring plans, reviewing essential regulatory documents, and resolving site-level issues promptly. The successful candidate will possess exceptional organizational skills, strong problem-solving abilities, and excellent written and verbal communication. This is a field-based role, requiring significant travel to clinical sites across the region, based out of our **Virginia Beach, Virginia, US** operational hub. Extensive knowledge of therapeutic areas and drug development processes is crucial. We are looking for a proactive individual who can independently manage multiple priorities and drive project success.
Responsibilities:
Responsibilities:
- Lead and manage clinical trial site activities.
- Conduct site initiation, monitoring, and closeout visits.
- Ensure compliance with ICH-GCP and regulatory guidelines.
- Oversee data integrity and patient safety.
- Mentor and train junior CRAs.
- Build and maintain strong relationships with investigators and site staff.
- Develop and implement study monitoring plans.
- Review regulatory documents and study files.
- Resolve site-level discrepancies and issues.
- Collaborate with internal project teams and stakeholders.
- Bachelor's degree in Life Sciences, Nursing, or a related field.
- Minimum of 7 years of experience as a Clinical Research Associate.
- Demonstrated experience in a Lead CRA or similar supervisory role.
- In-depth knowledge of ICH-GCP guidelines and FDA regulations.
- Experience in multiple therapeutic areas is a plus.
- Excellent written and verbal communication skills.
- Strong organizational and problem-solving abilities.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Willingness to travel extensively.
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6
Lead Clinical Research Associate (CRA)
20001 Washington, District Of Columbia
$100000 Annually
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Posted 7 days ago
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Job Description
Our client, a leading pharmaceutical research organization, is seeking a highly experienced Lead Clinical Research Associate (CRA) to join their esteemed team. This role is primarily based in **Washington, D.C., US**, with a hybrid work arrangement offering flexibility. You will play a pivotal role in the successful execution of clinical trials, ensuring adherence to protocol, regulatory guidelines, and Good Clinical Practice (GCP). The Lead CRA will be responsible for overseeing junior CRAs, mentoring them, and ensuring the quality and integrity of trial data across multiple sites. Your expertise will be crucial in managing investigator sites, monitoring patient safety, and ensuring timely completion of trial milestones. Responsibilities include conducting site selection visits, initiation visits, routine monitoring visits, and close-out visits; reviewing and verifying source documents against case report forms (CRFs); ensuring accurate and timely data entry; identifying and resolving site issues; and preparing comprehensive monitoring reports. You will also be responsible for training site staff on study protocols and procedures, acting as a liaison between study sites and the sponsor, and ensuring compliance with all regulatory requirements. A Bachelor's degree in a life science, nursing, or a related field is required; an advanced degree is a plus. A minimum of 5-7 years of experience as a Clinical Research Associate is essential, with demonstrated experience in a lead or supervisory capacity. Thorough knowledge of ICH-GCP guidelines and FDA regulations is mandatory. Strong understanding of clinical trial processes and therapeutic areas is expected. Excellent organizational, communication, and interpersonal skills are critical. The ability to travel to sites as needed is required. This hybrid role offers a fantastic opportunity to advance your career in clinical research within a supportive and innovative environment.
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7
Lead Clinical Research Associate (CRA)
73102 Oklahoma City, Oklahoma
$115000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a pioneering pharmaceutical company, is seeking an experienced and highly motivated Lead Clinical Research Associate (CRA) to join their dynamic clinical operations team. This hybrid role offers the flexibility to work remotely while also engaging in essential on-site activities, contributing to the successful execution of critical clinical trials. You will be responsible for overseeing and managing all aspects of clinical trial site management, ensuring compliance with regulatory requirements and company SOPs. Your expertise will be crucial in ensuring the integrity and quality of data collected, and the safety of trial participants.
Responsibilities:
Qualifications:
This position is based in **Oklahoma City, Oklahoma, US**, with a hybrid work arrangement allowing for a blend of remote and in-office responsibilities.
Responsibilities:
- Lead and mentor a team of CRAs, providing guidance and support in the conduct of clinical trials.
- Conduct site initiation, monitoring, and close-out visits to ensure compliance with protocol, GCP, and regulatory guidelines.
- Oversee the accurate and timely collection, review, and documentation of clinical trial data.
- Manage relationships with investigative sites, fostering strong collaboration and communication.
- Ensure all investigational product is accounted for and administered according to protocol.
- Identify, assess, and report adverse events and serious adverse events in a timely manner.
- Prepare and present monitoring reports, addressing identified issues and implementing corrective actions.
- Participate in the development and review of clinical trial protocols, informed consent forms, and other essential trial documents.
- Ensure timely resolution of site-specific issues and deviations.
- Stay current with relevant therapeutic areas, regulatory requirements, and industry best practices.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
- Minimum of 5 years of experience as a Clinical Research Associate, with at least 2 years in a lead or supervisory capacity.
- In-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant regulatory requirements.
- Proven experience in monitoring clinical trials across various phases and therapeutic areas.
- Excellent understanding of clinical trial processes from site selection to trial closure.
- Strong leadership, communication, and interpersonal skills.
- Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
- Ability to travel to clinical sites as required, balanced with remote work capabilities.
- Critical thinking and problem-solving abilities.
- Detail-oriented with a commitment to data accuracy and patient safety.
This position is based in **Oklahoma City, Oklahoma, US**, with a hybrid work arrangement allowing for a blend of remote and in-office responsibilities.
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8
Senior Clinical Research Scientist - Drug Development
68104 Omaha, Nebraska
$160000 Annually
WhatJobs
Posted 7 days ago
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Job Description
Our client is a globally recognized pharmaceutical company at the forefront of discovering and developing life-saving medicines. We are actively seeking a highly accomplished Senior Clinical Research Scientist to join our innovative drug development team, working entirely remotely. This pivotal role will drive the design, execution, and interpretation of clinical trials, contributing significantly to bringing novel therapies to patients worldwide. You will leverage your deep scientific expertise and leadership skills to guide critical research initiatives from concept through regulatory submission.
Responsibilities:
Responsibilities:
- Lead the development of clinical development plans and protocols for investigational drugs, aligning with strategic objectives and regulatory requirements.
- Provide scientific and strategic input throughout the clinical trial lifecycle, from study design to final report generation.
- Oversee the execution of clinical studies, ensuring adherence to protocols, good clinical practice (GCP), and regulatory guidelines.
- Collaborate with internal teams (e.g., Regulatory Affairs, Biostatistics, Data Management) and external partners (e.g., CROs, investigators) to ensure successful trial implementation.
- Analyze and interpret complex clinical data, contributing to safety assessments and efficacy evaluations.
- Author and review key study documents, including investigator brochures, clinical study reports (CSRs), and regulatory submissions (e.g., IND, NDA).
- Stay abreast of the latest scientific advancements, therapeutic area trends, and competitive landscape.
- Present clinical development strategies and study results to internal stakeholders, steering committees, and regulatory authorities.
- Provide scientific expertise and guidance to cross-functional teams and investigators.
- Contribute to the identification and evaluation of new drug candidates and research opportunities.
- Ph.D. or Pharm.D. in a relevant scientific discipline (e.g., Pharmacy, Biology, Biochemistry, Pharmacology).
- Minimum of 7 years of progressive experience in clinical research and drug development within the pharmaceutical or biotechnology industry.
- Demonstrated expertise in designing, executing, and managing clinical trials across various phases (Phase I-IV).
- Strong understanding of GCP, ICH guidelines, and regulatory submission processes (e.g., FDA, EMA).
- Proven ability to critically analyze and interpret complex clinical data.
- Excellent scientific writing and communication skills, with experience authoring protocols and CSRs.
- Demonstrated leadership skills and the ability to effectively influence and collaborate with diverse teams.
- Experience in a specific therapeutic area (e.g., oncology, immunology, neurology) is a strong asset.
- Ability to work independently, manage multiple projects simultaneously, and thrive in a fast-paced, remote environment.
- Strong problem-solving and strategic thinking capabilities.
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