Senior Clinical Research Associate Contractor (0.3 FTE)-Slovakia
Allucent, Slovakia
Job Description
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.
These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
Location: Slovakia
Therapeutic Knowledge: Oncology, Rare disease
Availability: 0.3 FTE
The Senior Clinical Research Associate contractor (SCRA - contractor) will be responsible for the following tasks:
- Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.
- Track and supervise collection of ongoing study data for purpose of regular project status reporting as required.
- Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies.
- Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.
- Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
- Collect and review regulatory documents as required.
- Prepare site visit and telephone reports.
- Responsible for multiple projects and must work both independently and in a team environment.
- May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
- Resolve site issues and determine status for IP shipment.
- Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts.
- May translate, coordinate translations or review completed translations of critical documents.
- Participate in feasibility and/or site identification activities.
- Assist the Project Team with the day-to-day management of clinical studies as required.
- Monitoring Visit Report (MVR) review, management, resolution and escalation as required.
- Train, mentor and/or supervise junior staff.
- May be assigned as LCRA to a regional or global study.
- May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
- Conducts project co-monitoring, assessment visits and team training.
- Site contact for protocol clarifications and subject enrolment if CRA unavailable.
- Participate in the development of study newsletters communication as required.
- Assist with the development of project-specific training materials for team.
- Liaise with Business Development and make presentations to potential clients as required.
- May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).
Requirements
- At least 5 years experience in clinical research
- Experienced in Study Start-Up, CRA and CTA tasks.
- Must have experience with RECIST 1.1 within the last two years
- Ideally has iRECIST experience
- Skills to mentor and train other CRAs in a positive and effective manner.
- In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
- Ability to travel on site per month, depending on the project needs.
- Strong therapeutic background.
- Has shown ability to successfully manage people/project issues.
- Mature management skills demonstrated by calm and thorough review of situations. Proactively