Descripción de la oferta
In a few words
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Position: Site Engagement and Recruitment Coordinator
Location: Poland
Experience: Minimum of 3 years of clinical trial experience, including previous experience as a Clinical Research Coordinator, Sponsor/CRO Clinical Research Associate, Study Nurse, or Site Director.
Want to know more?
#Exeltis is a leader in the field of ·# Women'sHealth . It researches, innovates and creates new treatments and devices to improve the health and wellbeing of women all over the world. With a global footprint spanning more than 40 countries, Exeltis has a team of over 4,000 professionals and a global manufacturing network.
Exeltis has one overarching goal: to offer women support and care throughout every single stage #OneHealth
Ready to be a #Challenger?
What are we looking for?
A Site Engagement and Recruitment Coordinator (SERC) who uses their strong clinical trial background and awareness of site engagement and recruitment tactics to support the clinical team in effectively planning for and achieving on-time enrollment. This position achieves these goals by working with the clinical team to proactively identify opportunities and challenges related to patient recruitment and retention. Supports the Global Clinical Operations Department by engaging, developing, and maintaining relationships with clinical investigation sites
and overseeing clinical trial activities to ensure quality clinical trial execution and offer innovative solutions to recruitment and operational challenges. The SERC reports to a designated Senior Clinical Project Manager.
The challenge!
The Site and Recruitment Coordinator’s responsibilities include, but are not limited to:
• Awareness of and active participation in activities of site-related study execution of assigned studies, including feasibility, study start-up, execution, and close-out.
• Early participation in and management of study planning and preparation regarding site recruitment and retention plans, enrollment projections, and anticipated barriers to achieving on-time First Patient In.
• Support oversight efforts related to collaborating CRO activities, including but not limited to:
o Study delivery: including but not limited to site evaluation/selection discussions, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure facilitation.
o Quality oversight: Monitoring Visit Report Review; Site Visit for site quality oversight as appropriate.
o Escalate performance or quality issues and support the resolution of identified issues.
oFacilitate supplemental site training or other support from the Sponsor team as needed.
o Support audit and inspection readiness goals for sites on assigned studies.
o Assist with and follow up on-site audits, CAPA preparation, implementation, and follow-up
communication.
• Independently serve as a key point of contact in the country or as a global representative for one or more studies.
• Drive project recruitment and retention strategy for assigned clinical trials by supporting the development of related communication to adapt, plan, and implement local study strategies for recruitment and retention.
• Participation in the review and finalization of key clinical trial documents, as assigned.
• Proactive and effective communication in collaboration with key internal & external stakeholders and third-party vendors. Develop partnerships (institutions and key investigator relationships) when appropriate and beneficial for the organization and/or assigned clinical trial(s).
• Lead investigational site engagement efforts:
o Define and implement strategies for successfully engaging clinical sites and investigators.
o Assist in identifying high-performing sites and key opinion leaders that can contribute to Exeltis forums, boards, and/or discussions.
o Support sites with enrollment barriers by reinforcing protocol-specific site recruitment plans,
including review and approval of advertising campaigns.
o Provide operational expertise to sites through ownership/management to ensure the engagement of highly motivated clinical investigators.
• Support global team by participating in or leading other tasks and projects as assigned.
Attributes and Actions Related to the Role
• Understanding and execution of recruitment plans, including control of digital recruitment.
• Identify the top recruiters and high-quality performers using different platforms, competitive intelligence, and contacts with KOLs and institutions.
• Attend TCs and MVR reviews, serve as a key point of contact with the CROs and other stakeholders, and identify recruitment issues. May lead meeting with internal and external colleagues.
• Follow-up and tracking of recruitment and retention rates. Close follow-up of screening failure and dropout rates and inactive sites, followed by a proactive proposal and implementation of mitigation actions.
• Periodical calls with the sites participating in clinical trials to enhance engagement and speed recruitment. Actively detect trends or issues for resolution management.
• Periodical presential meetings with the leading recruiters to boost the relationship and explain the Sponsor pipeline.
• Involvement in certain clinical site monitoring activities, including support in audits and RA inspections.
• Work with Clinical Operations to review and approve study and site-specific recruitment materials.
• Monitor weekly enrollment metrics and work alongside the clinical team to meet/exceed enrollment goals for assigned studies.
• Establish and apply best practices and lessons learned across all clinical studies.
• Track, analyze, and present data from central recruitment campaigns.
• Attend internal and external meetings and provide updates on recruitment and site activities.
Additional Contributions
• Consistently meet, at minimum, other key performance indicators (KPIs), personal performance and development goals, or improvement goals defined for the role or employee.
• May support clinical trials in a CRA or Sr. CRA capacity when needed, as directed, and according to the Clinical Research Associate/Senior Clinical Research Associate Job Description.
• May review trip reports for CRAs or perform as Manager/Line Manager for assigned CRAs.
• May be responsible for the preparation and presentation of information during Investigator Meetings or other site meetings.
• Contribute to the development and maintenance of the company’s SOPs and quality control procedures.
• May be requested to lead or contribute to company initiatives.
• Complete other duties as assigned.
What do you need?
• Education: Bachelor’s degree (or international equivalent), preferably in a scientific or health-related field.
• Languages: Fluent in spoken and written English. Knowledge of other languages will be an asset,
particularly local languages spoken within the regions of the assigned studies.
• Experience (years/area): Minimum of 3 years of clinical trial experience, including previous experience as a Clinical Research Coordinator, Sponsor/CRO Clinical Research Associate, Study Nurse, or Site Director. Prior CRA experience is essential for fulfilling flex role CRA tasks as necessary and assigned.
• Specific Knowledge: Prior experience conducting clinical research, including ICH-GCP knowledge and understanding, drug/device development process, regulatory compliance, regulatory agency requirements for clinical trials in the trial regions, study start-up, or study coordination.
• Travel Requirements: Required to travel approximately 40-50% of the time.
• Personal Skills: Strong communication skills, ability to focus on multiple deliverables simultaneously and deliver them on time, versatility and flexibility, general management skills, strong interpersonal and people development skills, results-oriented, superior leadership skills, superb organization skills, ability to anticipate problems and solve them successfully, and team player with the ability to work productively and independently in a remote professional environment.
What will the Selection process be like?
Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels.
Prepare well! We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test.
Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.
Do you think this offer is not for you?
Follow us on social media like LinkedIn/Instagram and stay tuned for any offers we may release; the opportunity to be a new Insuder is waiting! xiphteb
#Vetpharma #InsudPharma #Challenger #Insuder #InsudTalent
COMMITMENT TO EQUAL OPPORTUNITIES
The InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
