Clinical Research Associate MAP (remote-based)
- Permanent
- Clinical Operations, Monitoring
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Hobson Prior are currently in search for a Clinical Research Associate - MAP to join a fast-paced biopharmaceutical organisation who are creating ground-breaking products that have never been made before. The role will be on a permanent basis and to be able to work remotely anywhere across the East Coast USA.
Please note that to be considered for this role you must have the right to work in this location.
Key Responsibilities:
- You will be responsible to support the PM/Sr. PM in the site qualification and study site initiation processes including the conduct of Site Qualification and Site Initiation visits.
- You will lead numerous protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
- Guarantees quality of data submitted from study sites, collects data from sites within established timelines and ensures timely follow up/submission on any requested information.
- To work across functions in the Company to ensure the readiness of supply kits for patient visits.
- Conducts Site Initiation visits in collaboration with Medical Monitors and/or Clinical Project Managers where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements regularly.
- Independently performs monitoring visits including site initiation, qualification, routine monitoring and close out visits.
- Critically reviews and analyses site activities through frequent visits and contacts to monitor study sites following the applicable study plans and applicable SOPs, to assure compliance with the protocol, and IRB requirements.
- Confirms site compliance, safety, and protection of study patients according to the clinical study plans, SOPs, and ICH and/or FDA GCP Guidelines. Works with site personnel/study team to prevent address and resolve issues.
- Reviews adverse event reports (where required) and ensures site reporting of safety events in a timely manner.
- Any other assigned duties.
Key Skills:
- Capability to create and sustain effective working relationships with co-workers, managers, investigator site personnel and service providers.
- Excellent communication, interpersonal and organizational skills.
- Effective problem-solving skills.
- Attention to detail and meet specified timelines.
- Computer literacy, proficiency in Microsoft Office.
Requirements:
- Bachelor's degree (BSc, BA or RN equivalent) in biological or science-related field is essential.
- A valid driving licenses.
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
- A minimum of 3-5 years' monitoring experience, working as a CRA, in small pharmaceutical/biotech.
- Experience in monitoring oncology early phase studies.
- Experience with ATIMPs an advantage.
- Strong clinical, technical or disease area expertise.
- Knowledge of medical terminology and clinical patient management.
Apply now:
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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