Associate Director Clinical Research Jobs

5+ years of relevant experience in site monitoring and clinical project management.

Project management and organizational skills.

Communicate study progress to management.

Understanding of clinical trial process, data management, and analysis.

Manage clinical monitoring, site compliance, and adherence to protocols.

Experience in medical device, in-vitro diagnostics, or pharmaceutical studies.

Ability to independently prioritize tasks with excellent time management skills.

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans.

Perform other duties as assigned by management.

Excellent verbal and written communication skills and conflict resolution abilities.

Oversee and conduct monitoring activities, including remote monitoring and risk-based monitoring.

Lead assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.

High organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budget

Approximately 2-5 years of on-site and remote monitoring experience

Broad range of therapeutic experience

Superior written and verbal communication skills

Wren Nursing (Clinical Trial Home Nursing & Clinical Education)

Contribute to the development of protocols, study tools, materials, and documentation for clinical sites.

Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training

Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion

Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills

Extensive knowledge of FDA regulations and their practical implementation

2 years of prior experience as a Clinical Research Associate preferred

Full medical, dental, and vision benefit packages

Assist with site audits and site quality management activities, as needed.

Ensure monitoring activities (remote and on-site) are completed in accordance with Agilent procedures and study monitoring plan.

Assures adherence to GCP, study protocol, and all applicable requirements through routine monitoring visits.

2+ years direct clinical research experience at a sponsor or CRO as a CRA/study monitor, or equivalent experience.

Diagnostic/IVD experience highly preferred, oncology or other medical device experience is also accepted.

Previous experience with NGS, IHC, or pathology highly preferred.

Position Requirements: Bachelor's degree in a Life Science or related field with 2+ years’ experience in laboratory experience.

Location:West Sacramento CA 95691 United States

Pay Rate:$45/ HR to $50/ HR

Escalate any site issue to the Clinical Trial Manager and/or study team, as needed.

Develop in-depth knowledge in relevant indications and clinical study methodology.

BA degree or RN or higher, preferentially in sciences/medical sciences, or equivalent experience.

At least 5 years of clinical monitoring experience.

At least 8 years of experience in the pharmaceutical industry or clinical research site-based experience.

Knowledge of ICH GCP guidelines.

Prior significant clinical/scientific background and/or education is required.

Serve as the primary point of contact for investigational sites.

Conduct investigational product accountability to ensure accuracy, proper storage, dispensation and reconciliation.

It’s More Than a Career, It’s a Mission.

About Sarah Cannon Research Institute

Look for candidate who has some documentation and some clinical research experience and computer savvy

System used is called CDO Gateway for the regulatory docs - medical documents experience is NOT required

Will consider someone with No College Degree as long as they have the necessary experience

Duration:04-05 months Contract, may extend further depends on the business need of project and performance.

will be reviewing regulatory documents, uploading, filing them and moving to their program.

Must be self-motivated, analytical, organized, and exercise accuracy

Excellent interpersonal, judgment, and time management

You will also manage regular site liaison, tracking, query resolution, and maintaining investigator site file and TMF.

Approximately 3-5yr Experience as Clinical Research Associate

Fundamental knowledge and good understanding of GCP’s, clinical study development process, and logistics.

Proficient knowledge of MS Office Applications (Word, Excel, PowerPoint, Etc.

Support study start-up activities including site selection, collecting essential documents and CTRA, register study on ANZCTR.

Experience in operation of multiple flow cytometry platforms (e.g.: Client, Sony, etc.) and specialized analysis software (e.g.: FlowJo, ...)

Previous experience with flow cytometry, hands-on experience in developing flow cytometry-based methods.

Hands-on experience with gene editing technologies is a plus.

Prior experience with the following is preferred

Cell isolation, sample preparation and staining

Must be proficient in cell-based assay development and molecular techniques.

Previous experience of sharing knowledge, key learnings and best practice from experiences on the projects that they have been responsible for

Previous experience moderating a range of face-to-face and online sessions, and facilitating both client and consumer workshops

Previous experience of managing and leading end-to-end qualitative projects

Leads and takes responsibility for the successful on-time and on-budget delivery of projects that generate top quality results.

Prepares creative and innovative proposals

Alternatively, you should have an equivalent combination of education, training and experience

A Bachelor's degree in a health care or other scientific discipline or educational equivalent

At least two years of on-site monitoring experience

Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation

Supporting the development of a subject recruitment plan

Establishing regular lines of communication plus administering protocol and related study training to assigned sites

Strong Benefits And Compensation Package

Clinical Research Associate opportunity in the oncology space!

Want to learn more about this role and Jobot?

Strong Benefits And Compensation Package

Clinical Research Associate opportunity in the oncology space!

Want to learn more about this role and Jobot?

Oversee site management responsibilities for assigned sites.

Assist in the management of routine trial activities, adhering to industry and corporate standards.

Support the Study Team/Management in all phases of the clinical trial.

Manage trial-specific Trial Master File (TMF) and internal filing system, including regulatory and legal document tracking and archiving.

2+ years of experience in a sponsor or CRO setting (strongly preferred).

Knowledge of clinical research in Cardiology/Medical Devices

Extensive knowledge of clinical trial procedures, GCP, and regulatory requirements

Excellent attention to detail, strong multitasking abilities, and effective communication skills

Experienced CRA Consultant - Midwest Region | Join a Leading Medical Devices Research Team!

Manage adverse events and ensure proper reporting according to industry standards

Stay abreast of the latest clinical trial processes, GCP, and regulatory requirements

Minimum of 5 years' experience as a CRA, preferably in medical devices

Assist with site audits and site quality management activities, as needed.

Ensure monitoring activities (remote and on-site) are completed in accordance with Agilent procedures and study monitoring plan.

Assures adherence to GCP, study protocol, and all applicable requirements through routine monitoring visits.

3+ years direct clinical research experience at a sponsor or CRO as a CRA/study monitor, or equivalent experience.

Diagnostic/IVD experience highly preferred, oncology or other medical device experience is also accepted.

Previous experience with NGS, IHC, or pathology highly preferred.

Excellent project management skills and familiarity with GxPs.

Perform noncompartmental PK and PD analyses of clinical trial data and collaborate with Data Management to ensure compliance with CDISC standards.

Collaborate with senior staff to develop strategies and direct efforts in clinical pharmacology to meet regulatory requirements.

A minimum of 7 years relevant experience in the biotech/pharmaceutical industry; minimum of 3 years in large molecule clinical pharmacology experience.

Experience in the design, coordination, and implementation of clinical studies.

Hands-on experience with noncompartmental PK analysis of clinical trial data and familiarity with CDISC standards.