FSP CRA II - Alzheimer's Experience - US West

Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, health sciences, healthtech, and IT. This role supports clinical trial monitoring and site management for Alzheimer’s studies, ensuring protocol, regulatory, and ICH-GCP compliance, data reliability, audit readiness, and effective communication with investigative sites and project teams.

Responsibilities

Monitors investigator sites with a risk-based monitoring approach: applies rootcause analysis (RCA), critical thinking and problem-solving skills to identify siteprocesses failure and corrective/preventive actions to bring the site intocompliance and decrease risks. Ensures data accuracy through SDR, SDV andCRF 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

Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO)

10 paid holidays annually

Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)

Accident and life insurance

Short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Remote work

Company

AI-powered talent hiring platform for life sciences, pharma, and IT

London, England, GBR

https://lifelancer.com/

Founded in 2020

11-50 employees

Qualifications

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

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 detailand 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

Good presentation skills

Required skills

Clinical Monitoring, Alzheimer’s Disease, ICH-GCP, Risk-Based Monitoring, Root Cause Analysis, Clinical Trial Management Systems, Medical Terminology, Regulatory Compliance, Microsoft Office

Preferred skills

Written and Oral Communication

Experience

2+ years