Senior Clinical Research Associate

Mindlance; Arizona; Presencial; USD 121.000 - 129.000; Jornada completa

Descripción de la vacante

Mindlance seeks a Senior Clinical Research Associate for a 6-month assignment with potential extension. The role involves remote or on-site visits and 80% travel across the West Coast to monitor trials and ensure regulatory compliance.

Responsibilities include risk-based monitoring, SDR/SDV, site management, and coordinating with sponsors. Strong ICH-GCP knowledge, precise documentation, and timely issue resolution are required.

Formación

• Bachelor's degree in life sciences or RN certification or equivalent.
• 2+ years of clinical research monitoring experience or equivalent.
• Valid driver's license where applicable.

Responsabilidades

• Monitor investigator sites using a risk-based approach and ensure data accuracy (SDR/SDV) and CRF reviews.
• Provide trial status updates and maintain CTMS data.
• Participate in investigator meetings and site initiation, monitoring, and close-out activities.
• Ensure essential documents are complete per ICH-GCP and regulations.

Conocimientos

Clinical monitoring

Risk-based monitoring

SDR/SDV

Documentation

Communication

Time management

Teamwork

Educación

Bachelor's degree in life sciences or RN

Herramientas

CTMS

MS Office

Descripción del empleo

Role: Senior Clinical Research Associate

Duration: 6 months with possible extension

80% travel required throughout the West Coast region

Pay rate: $58- $62/hr on W2

Summarized Purpose:

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Functions:

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
• Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Performs
• additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to other project work and initiatives for process improvement, as required

Education and Experience:

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years as a clinical research monitor).
• Valid driver's license where applicable.
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Effective clinical monitoring skills;
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Ability to manages Risk Based Monitoring concepts and processes
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Effective interpersonal skills
• Strong attention to detail
• Effective organizational and time management skills
• Ability to remain flexible and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills

About Mindlance:

Advance your career with Mindlance! We have been connecting talented IT professionals with world-class companies since 1999. Mindlance is here to help you to find the perfect fit with just the right company. Currently, we are seeking an Operational Analyst for an exciting career growth opportunity.

Make your next big career move with the kind of position that will allow you to be genuinely passionate about the work you do! Our recruiters will work closely with you to help you get the edge over the competition. Let Mindlance advocate for you – apply today!

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”