Associate Clinical Research Specialist Jobs

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

• Demonstrated experience in establishing and maintaining effective relationships with management, peers and subordinates and customers.

5) What are the top 5 skills/requirements this person is required have?

• Manage and prioritize work load, multi-task and manage a diverse mix of issues, responsibilities and challenges.

a. Required Skill 1: Organized and great attention to detail

b. Required Skill 2: Strong communication skills and intrapersonal skills

c. Required Skill 3: Takes initiative and works well alone and also within a team

Assist with essential documents collection, review and archiving (TMF management)

Provide project management support for PTX project team, including vendor oversight

Conduct Site Initiation, Routine, and Close-out monitoring site visits, either on-site or remotely, prepare visit correspondence and records including trip reports

Oversee the conduct of assigned study sites, including ensuring compliance with SOPs, federal and local regulations, and ICH and GCP guidelines

Assist in the review and /or development of clinical trial documents such as study plans and training materials

Participate in and assist with facilitation of project team meetings

· Prepares and attends assessment visits with less experienced CRAs, as required.

· Sound knowledge of medical terminology.

· Excellent communication in English in both written and verbal skills.

· Excellent interpersonal and organizational skills.

· Ability to manage more than 1 study simultaneously.

· Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.

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

A minimum of one (1) year experience in site oversight and management.

Expertise in oversight and managementvendors.

Company offers a great benefit package and competitive salary.

Assist the Study Lead carry out the responsibilities necessary to meet the constraints for the study.

Support clinical finance and the study's lead in evaluating, tracking, and directing study-specific budgets.

Three (3) or more years of experience in Clinical Research.

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 with Clinical Trials Management System (i.e., OnCore, Velos, etc.)

Organize and manage time and tasks independently

2 years of health care operations experience preferably in clinical research

Demonstrated skills in critical thinking and problem solving

Strong written and verbal communication skills

2 years of clinical research experience

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.

Your responsibilities as the Research Specialist will include:

To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay

Cell processing and tissue culture. Isolate and process fibroblasts from murine skin samples. Maintain cell cultures for differentiation assays.

Maintain mouse colonies (set up breeding, monitor health and maintain records).

Perform in vivo wound healing or tumor studies in mice.

Perform tissue fixation, embedding and sectioning for histology.

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

Utilize systems and technology for account management tasks

Remote work-from-home position with flexible schedules

Comprehensive benefits package including medical, dental, vision, and life insurance

Excellent communication skills, both written and oral

Basic knowledge of Microsoft Office Suite and Windows operating system

Strong problem-solving and conflict resolution skills

Strong Benefits And Compensation Package

Clinical Research Associate opportunity in the oncology space!

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