Sr. Clinical Research Associate (Americas)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Sr. Clinical Research Associate (sCRA I) to join our A-team (remote, with travel). As a sCRA I at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.

Therapeutic Area{​{:}} CAR-T and/or stem cell, Oncology, and/or COVI

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In this role your key tasks will include{​{:

}
• } Governs highest possible quality standards for trial monitoring activities
.
•   Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours.
 
•   Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines{​{:
}
• }  Performs efficient site management in line with study budget
.
•    Prepares and submits quality Site Visits Reports and Contact report
s
• .  Maintains and updates CTMS in compliance with SOPs and study-specific directive
s
• .  Acts as Document Owner for collected document
s
• .  Conducts co-monitoring as neede
d
• .  Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF
)
• .  Liaises with project team members and Sponsor to track study progress and milestone
s
• .  Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timeline
s
• .  May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR)
.
•    May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA trainin
g
• .  May perform assessment visit
s
• .  Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personne
l
• .  Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolutio
n
• .  Acts as the lead contact in case several CRAs involved for a same study in same countr
y
• .  Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when neede
d
• .  May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicabl
e
• .  May participate in meetings with client
s
• .  May support project manager/CTL and project functional leads in the project oversight and managemen
t
• .  Supports site staff in preparation for study related site audits and inspection
s
• .  Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Action
s

ntsTo be successful you will possess{​

{
• :}} At least five years clinical monitoring experience and/or relevant clinical trial experien
c
• e.  Relevant life science degree / medical / nursing background, or combination of education and experien
c
• e.  Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedure
s
• ..  Strong written and verbal communication skills including good command of English and local languag
e
• .   Representative, outgoing and client focuse
d
• .   Ability to work in a fast-paced challenging environment of a growing compa
n
• y.  Administrative excellenc
e
•     Proficiency with various computer applications such as Word, Excel, and PowerPoint requir
e
• d.  Effective clinical monitoring skills (all kind of visits mastered){​
{
• :}}  Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminol
o
• gy.  In-depth knowledge of clinical trials and the critical elements for success in clinical tri
a
• ls.  Excellent understanding of the drug development proc
e
• ss.  Ability to proactively identify and resolve issues in a timely man
n
• er.  Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical person
n
• el.  Effective organizational and time management ski
l
• ls.  Ability to manage multiple projects and strong attention to det
a
• il.  Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clie
n
• ts.  Ability to meet project requiremen
t
• s.   Proven flexibility and adaptabil
i
• ty.  Ability to work in a team or independently and to effectively prioritize ta
s
• ks.  Ability to perform travel an average of 8 days on site per month, depending on project
n

efitsBenefits of working at Allucent include

{
• ​{:}} Comprehensive benefits package per lo
c
• ation Competitive salaries per loc
a
• tion Departmental Study/Training Budget for furthering professional develo
p
• ment Flexible Working hours (within re
a
• son) Opportunity for remote/hybrid* working depending on lo
c
• ation Leadership and mentoring opportun
i
• ties Participation in our Buddy Program as a new or existing em
p
• loyee Internal growth opportunities and career progre
s
• sion Financially rewarding internal employee referral pr
o
• gram Access to online soft-skills and technical training via GoodHabitz and internal pla
t

f

orms Disclaimer

s{​{:}}*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global o

f

fices. "The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human reso