Clinical Research Associate at BioClin Therapeutics B.V.
BioClin is looking for a looking for a highly motivated, hands-on and passionate (Sr.) Clinical Research Associate (In-House) to expand their clinical operations team at our EU headquarters in Leiden, the Netherlands.
This is an unique opportunity for a Clinical Research Associate, with a "Yes Can Do mentality", who wants to expand their current experience in international clinical trials, in a dynamic biotech environment and an oncology indication.
BioClin Therapeutics, Inc. is a privately-held biotechnology, based in San Francisco (United States) and Leiden (Netherlands) and is developing a first-in-class anti-FGFR3 antibody (B-701). Our Phase 2 program, B-701, is the only biologic targeting FGFR3 in clinical development. We are exploring B-701 as mono therapy, and in combination with standard-of-care chemotherapy, as well as with a checkpoint inhibitor in metastatic bladder cancer.
Location: Leiden, The Netherlands
Department: Clinical Operations
Reports To: Manager or above
The (Senior) Clinical Research Associate (In-House) role will be a key contributor to BioClin’s clinical development programs. This person will assist Study Leads in administrative and operational aspects of study lifecycle across multiple activities.
Key duties and resposibilities
- Provide input to or develop study-related materials such as protocols, study plans & guidelines, eCRF forms, and patient informed consents
- Ensure proper conduct of clinical trials in accordance with the Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and BioClin standards to achieve project goals, timelines and quality
- Identify, evaluate and select investigator sites as needed
- Liaise or manage external vendors as needed
- Interface with the study team; facilitate information flow between members of the study team, vendors and assigned investigator sites
- Oversee investigator site activation activities, including Investigator Initiation Package (IIP) completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation
- Attend investigator meeting when required and develop/conduct investigator meeting presentations and/or trainings as required
- Provide enrolment support to and ensure progress by responding to site staff issues
- Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure visits and with study team members and/or CRO CRAs as needed
- Track all required reports, documentation, updates within required timeframes, including but not limited to Trial Master File documentation, monitoring visit reports, site visit follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
- Support study team as needed with Regulatory, Central, and Local Ethics Submissions and responses
- Support clinical database release, SAE reconciliation, and resolution of data queries within required timelines
- Assist or manages adequate investigational product at investigator sites, as well as import license and clinical supply depot activities
- Assist or manages trial tissue sample tracking and lab vendor interactions
- Proactively identify, manage and escalate site issues
- In collaboration with appropriate study team members, identify study quality issues and assist with creation and implementation of corrective actions and preventative actions (CAPA) as needed
- Assist/develop site communications, including but not limited to letters/memos, slide presentations, study newsletters
- Train Clinical Research Associates and/or Assistants as assigned
- MSc degree in (bio) medical/pharmaceutical sciences
- Typically requires a minimum of two years of related experience in clinical trial operations and/or combination of experience and education/training
- Experience in Biotech/Pharmaceutical industry preferred
Personal & Professional Skills:
- Knowledgeable in GCP and ICH requirements
- Understanding of clinical trial methodology and operations
- Oncology therapeutic area knowledge is preferred
- Knowledge of clinical trial databases and IRT systems
- Experience in site monitoring as a CRA is preferred
- Ability to organize and prioritize several tasks and complete them under time constraints
- No 9-5 mentality: able and willing to work flexible hours including evening hours as needed
- Excellent interpersonal, oral and written communication skills in English
- Proactive work style and creative problem-solving skills
We offer you a highly dynamic job in an international drug development environment working on a first in class product in bladder cancer on a global scale. The position is office based but we are flexible with working from home. Position will involve some international travel. You will be working in a small global team of experienced, passionate, innovative and motivated drug development professionals, all with a patient focus and a no-nonsense mentality.
BioClin offers great benefits including a competitive salary, bonus, 25 holidays, pension and health insurance.
Contact us per email or phone and we will provide you with more information.