Clinical Research Associate

Mindlance; Georgia; Remote; USD 90,000 - 120,000; Full time

Job summary

Mindlance is seeking a Clinical Monitoring Specialist to manage site monitoring for clinical trials. The role conducts remote or on-site visits to verify protocol adherence, regulatory compliance, and data integrity, maintaining audit readiness.

Responsibilities include coordinating with investigators and sponsors, performing SDV/SDR checks, and updating CTMS. A life sciences degree or RN and 2+ years of monitoring experience, plus a valid driver’s license, are required.

Qualifications

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

Responsibilities

• Monitor investigator sites using risk-based monitoring; apply RCA and CAPA to ensure compliance.
• Perform SDR, SDV and CRF review to ensure data accuracy.
• Coordinate visits and ensure protocol adherence and regulatory compliance.
• Maintain essential documents per ICH-GCP and regulatory requirements.
• Contribute to project team with timely reports and issue escalation.
• Update CTMS and support investigator payments and site close-out.

Skills

Clinical monitoring

Risk-based monitoring

Root cause analysis

ICH-GCP knowledge

SDV/SDR review

CTMS proficiency

Regulatory compliance

Effective communication

Time management

Microsoft Office

Education

Life sciences degree

RN certification

Tools

CTMS

Job description

Duration: 06+ months with possible extension

Location: Remote (East Coast – GA, FL, NC)

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 pplicable
• 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 flexibile 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

EEO

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