Associate Clinical Research Specialist Jobs in California

Conduct study site selection, qualification, training, start up, and close out .

Assist with data entry as necessary.

-A minimum of 2 years' direct experience in clinical study monitoring is required.

-Experience in IVD studies is preferred, with a proven track record of progressive clinical study responsibility.

-Knowledge of medical terminology and good clinical practice required.

Detail-oriented with a high level of organizational skills.

Qualification / Education/ Experiences/ Skills

Late-stage clinical trial experience and working knowledge of US regulatory agency requirements, preferred

Conduct medical monitoring, pharmacovigilance, regulatory, data management related to delegated clinical study.

Manage investigational product (IP) accountability and reconciliation process

Minimum BA/BS in scientific, life science, or related field with 2+ years CRA related experiences

Sponsor-side clinical trial experience in the pharmaceutical industry is preferred

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

Please update the minimum qualifications below to reflect the requirements for your specific role.

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.

Bachelor’s degree REUIRED WITH A PREFERANCE IN Biological Sciences which fit best BUT “Life Sciences” degrees will also be considered

Minimum of 3 to 5 years of clinical exp. within industry

Specifically looking for monitoring exp. on the sponsor side

Will be supporting a multi-site study

Will be doing monitoring visits

Medical device exp. of at least 1 year

• Minimum of 3 to 5 years of clinical exp. within industry

• Specifically looking for monitoring exp. on the sponsor side

• Will be supporting a multi-site study

• Exp. with site selection

• Will be doing monitoring visits

• Medical device exp. of at least 1 year

2 years of related experience in supporting medical device clinical trials

Strong interpersonal and communication skills

Able to manage multiple tasks

Experience working directly with US and EU sites strongly desired

Experience working with clinical data and databases (desirable)

Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation

Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements

Thorough knowledge of monitoring procedures; Basic understanding of the drug accountability process

Good planning, organization and problem-solving abilities; Ability to work with minimal supervision

Organize and make presentations at Investigator Meetings

Participate in the development of protocols and Case Report Forms as assigned

Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

Participates in required training and education programs.

1 year Clinical Research Related Experience

Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.

Evaluates and abstracts clinical research data from source documents.

Ensures compliance with protocol and overall clinical research objectives.

Completes Case Report Forms (CRFs).

Maintains all DSMC required documentation and ensures accurate recording of DSMC reviews into the clinical trial management system (OnCore).

Works with CCTO management to establish and optimize metric reports.

Assists in management of SOCCI Protocol Review and Management Committee by serving as a backup when necessary.

Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.

3 years of related experience in a similar position is required.

Prior monitoring or auditing experience in clinical research preferred.

Manages submission of documents and maintenance of the Trial Master File (TMF); reviews TMF to ensure inspection-readiness

At least 2 years of relevant experience in the pharmaceutical industry, Biotech or equivalent

Knowledge of GCP and ICH guidelines required

Excellent communication and interpersonal skills

Strong computer skills in MS Word, Excel, Outlook, and PowerPoint

Responsible for ensuring external service providers execute activities in a quality manner and per the established contract