Senior CRA (CRO Management) - Proteus Digital Health - Redwood City, CA

Senior CRA (CRO Management) - Proteus Digital Health - Redwood City, CA -

Job Description

The power and tradition at Proteus is a contagious mixture of ardour, focus, relentless willpower, and critical enjoyable. Proteans are mission-minded and collaborate in a method that’s refreshingly encouraging. With all of this comes success after which progress, which is why you’re studying this now as a result of we’re in search of a extremely motivated Senior CRA (CRO Administration) to hitch us onsite at our Redwood Metropolis, CA headquarters.

On this position, you’ll help the event of efficacy and security knowledge on Proteus Digital Health research, and help with the execution of medical packages for assigned product(s). You’ll additionally work with excessive-performing, options-pushed staff members whereas working cross-functionally with a number of inner groups. However it doesn’t finish there. Right here’s a abstract of this nice alternative:

Oversee a number of research and every day actions which can differ relying on the kind of medical research

Handle contract analysis group (CRO) workforce members and research websites

Guarantee research are accomplished on time, inside price range and in compliance with the protocol, GCPs, FDA laws and ICH/GCP tips, and general medical goals

Handle all operational research parameters together with, however not restricted to, medical research begin-up actions, medical provides preparation, enrollment, knowledge assortment, and shut-out

Supervise monitoring actions of research knowledge verification on supply documentation and case report types (CRFs) to make sure compliance with the research protocols, GCPs, and SOPs; Guarantee knowledge discrepancies are recognized and resolved

Put together and oversee all research-associated medical paperwork together with, however not restricted to, knowledgeable consent varieties, website coaching supplies, CRFs, medical monitoring plans, supply doc templates, and knowledge audit worksheets

Co-monitor on-website monitoring visits, together with website qualification, initiation, interim, co-monitoring with CRO, and shut-out visits as crucial; Assessment website go to reviews and supply well timed enter to CRO

Lead the planning of medical conferences (investigator assembly, CRO kick-off conferences, and so forth.)

Function the lead medical operations consultant in venture group conferences

Help the group in sustaining a piece setting targeted on high quality that fosters studying, respect, open communication, collaboration, integration, and teamwork

Show efficient time management and prioritization expertise with a view to meet timelines, every day metrics, and group aims

Develop sensible approaches to medical and regulatory processes

Might oversee the actions of CTCs and CRAs

As much as 10% journey expectation, home Qualifications

BS diploma in a life science or a associated subject

6 to eight years of expertise as a Medical Analysis Affiliate or comparable position in a big pharmaceutical firm

5+ years of medical gadget, biotech or pharmaceutical analysis expertise

three to four years of profitable, extensive-ranging expertise managing contract analysis group (CRO) group members and research websites, together with research begin-up via research upkeep and shut out, with a demonstrated understanding of the info management elements wanted in a trial, together with enrollment projections, management and methods

Strong expertise utilizing Medical Operations Techniques (IVR, EDC)

In depth expertise within the preparation, monitoring, and execution of medical research

Excellent verbal and written communication expertise

Wonderful organizational expertise together with robust consideration to element

Capability to work each independently and collaboratively with cross-useful groups

Extremely proficient with Microsoft Workplace Suite and Gantt charts

Capacity to make the most of essential considering to research issues which can require a number of elements and approaches

Fascinating Qualifications

Primary understanding of Good Medical Apply (GCP)

Expertise in a begin-up or early stage firm surroundings

Capable of mentor and help within the improvement of different medical analysis group members

2+ years of prior challenge and other people management expertise

Further Info

Prepared for the journey of your life? We’re wanting ahead to receiving your resume!

We offer our staff with an excellent advantages package deal, which incorporates: medical/dental/imaginative and prescient insurance, 401Okay, paid time without work (PTO)—together with your birthday off, worker inventory choices, a brilliant & awesomely designed bodily work area, a complimentary wearable system (i.e. Fitbit), health facilities, and, in fact free snacks & drinks.

About Us: Proteus has acquired FDA market clearance within the U.S. and a CE mark in Europe for its wearable and ingestible sensor units. Headquartered in Redwood Metropolis, Calif., Proteus is privately held and funded by Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic, Novartis, Otsuka, Oracle, ON Semiconductor and different buyers.

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