Coordinates all clinical research activities with minimal supervision, adhering to service values and research ethics.
Compensation
$59,280.00-$96,928.00 Salary
Responsibilities
Coordinates and oversees all aspects of clinical research projects, including study start-up, site qualifications, initiation, monitoring, and close-out visits.
Oversees site visits, promptly addresses sponsor queries, and ensures strict adherence to study protocols and regulatory requirements.
Manages regulatory compliance and documentation processes, including preparing and maintaining regulatory documents, registering studies on clinicaltrials.gov, assisting investigators with regulatory submissions to the FDA, and developing/updating Standard Operating Procedures (SOPs).
Promotes ethical conduct in research and ensures integrity in all aspects of study conduct and data handling.
Manages logistical and administrative aspects of clinical research projects by maintaining inventory of supplies and equipment, preparing lab kits and requisitions, organizing/maintaining study documents, tracking deadlines for grants/deliverables, and constructing codebooks for data dictionaries.
Requirements
Bachelor’s degree
Nice to have: Two-three years with complex research projects
Clinical Research Associate responsible for clinical trials in the medical device sector, supporting centers from initiation to closure while ensuring data quality and compliance.
Locations (2)
Diegem, Flemishant, Belgium
Belgium
Responsibilities
Studiecentra begeleiden vanaf de opstart tot de studieafsluiting.
Monitoringbezoeken uitvoeren volgens het protocol en de GCP-richtlijnen.
De datakwaliteit en patiëntveiligheid tijdens klinische studies bewaken.
Studiecentra ondersteunen bij operationele vragen en documentatie.
De rekrutering, retentie en voortgang van studies actief opvolgen.
Play a critical role in the successful execution of clinical trials by independently coordinating daily study activities and ensuring compliance with protocol requirements, regulatory standards, and patient safety guidelines.
Responsibilities
Independently coordinate and manage industry-sponsored clinical trials from study start-up through closeout with minimal supervision
Manage complex study visit schedules and protocol-related activities while ensuring adherence to study timelines and requirements
Lead patient recruitment and retention efforts including chart review, patient outreach, informed consent discussions, and enrollment tracking to support study enrollment goals
Conduct protocol-required patient visits and assessments in accordance with study protocols, GCP guidelines, and site SOPs
Perform protocol-required clinical procedures including vital signs, ECGs, specimen collection, investigational product accountability, and phlebotomy
Requirements
Associate’s or Bachelor’s degree in a scientific, healthcare, or related discipline
Nice to have: gastroenterology
Nice to have: hepatology
Nice to have: cardiology
Nice to have: CCRC® — Certified Clinical Research Coordinator
Providing medical and scientific oversight for clinical trials, ensuring that study protocols are scientifically sound and aligned with regulatory requirements.
Collaborating with clinical operations, regulatory, and safety teams to drive the successful execution of clinical development programs.
Developing and reviewing clinical study protocols, investigator brochures, and other key study documents.
Interpreting clinical trial data and providing medical insights to inform decision-making and guide clinical development strategies.
Building relationships with key opinion leaders, investigators, and external stakeholders to support clinical development initiatives.
Considered as the primary sponsor point of contact for the investigative site. Advanced level of competency in providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening Abbvie's positioning.
Responsibilities
Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards
Align, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles
Support, guide, and mentor junior personnel on Site Management activities
Customize site engagement strategy for assigned study/ies
Gather local/site insights and utilize site engagement tools to report/track progress and measure impact
Requirements
Medical
Scientific
Pharmacy
Nursing
Nice to have: 2 years in independent clinical research monitoring of investigational drug or device trials
Oversee all regulatory operations for Sarah Cannon site Clinical Operations, develop and implement regulatory compliance strategies, manage FDA compliance and audits, and coordinate with industry sponsors and investigators.
Compensation
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
Responsibilities
Manage, direct, plan, and schedule activities and programs for the regulatory department
Establish and enforce procedures that assure all trial teams and sites are fully compliant with applicable laws, regulations, SOPs, and guidelines
Develop and implement regulatory policies and procedures for the sites and the site Clinical Operations team
Manage regulatory affairs for multiple clinical trials according to FDA and GCP guidelines
Manage relationships between industry partners and the FDA regarding regulatory compliance and audits
Requirements
Bachelor's Degree
Nice to have: 5+ years in clinical research
Nice to have: clinical research corporation experience
Responsible for managing the end-to-end process of resolving data discrepancies between clients and the Labcorp database, ensuring accurate, timely responses and compliance with GCP guidelines.
Responsibilities
Analyze and resolve client-reported data discrepancies, updating databases as required and in compliance with applicable GCP guidelines.
Lead cross-functional communications to drive discrepancy resolution through to completion.
Perform data revisions ranging from basic to highly complex, adhering to established data revision and data cleaning processes.
Provide clear responses to client inquiries and recommend alternative solutions when requests are not feasible.
Engage internal stakeholders in decision-making processes to ensure business needs are understood and addressed.
Requirements
Bachelor’s degree in life sciences or related field
Nice to have: Bachelor’s or master’s degree in science, Life Sciences, Data Management, or related field
Nice to have: minimum of 4 years of professional experience
Responsible for managing end‑to‑end data discrepancy resolution between clients and Labcorp databases, ensuring compliance with GCP guidelines and maintaining data integrity.
Responsibilities
Analyze and resolve client‑reported data discrepancies
Lead cross‑functional communications to drive discrepancy resolution
Perform data revisions ranging from basic to highly complex
Provide clear responses to client inquiries and recommend alternative solutions
Engage internal stakeholders in decision‑making
Requirements
Bachelor’s degree in life sciences or related field
Nice to have: Bachelor’s or master’s degree in science, Life Sciences, Data Management, or related field
Nice to have: Minimum of 4 years of professional experience
Support the clinical team in the development and execution of innovative patient recruitment and site engagement strategies.
Compensation
The anticipated salary range for this role is $85,000 - $105,000. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Responsibilities
Partner with the Clinical Trial Recruitment Managers to help plan & execute strategic initiatives for trial-specific patient recruitment and retention efforts for assigned clinical studies
Assist in the development of study-specific recruitment materials and help assess the feasibility of central recruitment campaigns
Collaborate with selected recruitment vendors that offer innovative solutions or approaches
Provide feedback to Clinical Trial Recruitment Managers on recruitment materials (written content and design elements) before the Clinical, Regulatory, and Medical reviews
Monitor weekly enrollment metrics and work alongside the clinical team to meet/exceed enrollment goals for assigned studies
Requirements
Bachelor’s Degree in life sciences, health care or related discipline
Nice to have: digital marketing experience
Nice to have: rare disease / difficult to recruit populations
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