FSP-CRA II Neuro and rare disease experience a plus

The company is a global clinical research organization supporting pharmaceutical and biotechnology companies with clinical trials worldwide. The Clinical Research Associate II will perform and coordinate clinical monitoring and site management activities, ensuring protocol, regulatory, ICH-GCP, and SOP compliance while maintaining data quality and audit readiness.

Tags

Health Care

Life Science

Pharmaceutical

Artificial Intelligence (AI)

Accounting

Human Resources

Healthcare

Publishing

Biopharma

Bookkeeping and Payroll

Employment

Freelance

Responsibilities

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

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. Performs 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

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)

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 the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members

Contributes to other project work and initiatives for process improvement, as required

Benefits

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, and 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

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

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

London, England, GBR

https://lifelancer.com

Total Funding

$0.68M

2025-03-01

Pre Seed· $0.24M

2024-03-01

Pre Seed· $0.11M

2023-03-01

Pre Seed· $0.12M

Leadership Team

Jayesh Pandya

Co-Founder & CEO

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Qualifications

Bachelor's degree in a life sciences related fieldor 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 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship

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

Proven clinical monitoring skills

Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents

Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving

Ability to manage Risk Based Monitoring concepts and processes

Good 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

Good organizational and time management skills

Effective interpersonal skills

Attention to detail

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: solid knowledge of Microsoft Office and the ability to learn appropriate software

Good English language and grammar skills

Good presentation skills

Required skills

Clinical Monitoring, Medical and Therapeutic Area Knowledge, Medical Terminology, ICH-GCP, Risk-Based Monitoring, Root Cause Analysis, Microsoft Office

Experience

1+ years