Job type full-time
Not provided by employer
Full job description
At genesiscare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the worldClinical research associate role summary you will take responsibility for monitoring clinical studies ensuring that projects are conducted in accordance with applicable sops, regulations and ich guidelinesYou will be responsible for all aspects of the study at sites and ensure that the project managers (pm) are kept fully informed of all aspects of the projectYou will also ensure that project documentation is obtained and maintained in a timely and compliant manner accordingly to project requirements.
Reporting lines: as the clinical research associate (cra) you will report directly to a project manager (pm).
Reporting lines and direct reports may change from time to time in line with the requirements of the role.
Your key responsibilities:
Act as a member of the project team with the goal to contribute towards efficient management of trials;
Negotiate site budgets and assists with the execution of site contracts with support
From the legal department and pm;
Support recruitment of potential investigators, preparation of human research ethics committee (hrec) submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the pm;
Oversee all aspects of study site management to ensure high quality data resulting in
Consistently low query levels and in good quality assurance reports;
Establish, updates, tracks and maintains study specific trial management tools/systems, and status reports;
Perform pre study visits: discusses protocol, other available study documentation and study requirements with investigator and other trial staff, ensures that trial staff and site facilities and the site’s recruitment potential are in accordance with protocol requirements, local regulations, ich-gcp and gc cro’s sops;
Perform site initiation visits: trains investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ich-gcp and gc cro’s sops;
Perform site monitoring visits: ensures adherence to protocol, accurate data collection via source document verification per the monitoring plan, and investigational product/biological samples/supplies accountability;
Communicate effectively with site personnel, including the principal investigator (pi), and gc management to relay protocol/study deviations and ensure timely implementation of corrective actions;
Develop and maintain strong working relationship with investigators and study staff, serving as an ambassador to promote gc`s high quality and ethical image;
Maintain study tracking, in accordance with the demands of the study;
Understand and updates clinical trial management system (ctms) in a timely manner;
Monitor and update data in an electronic data capture (edc) system in a timely manner and in accordance with study specific guidelines;
Perform data management review, including in-house crf review, and alert pms
And data managers to emerging issues with crf completion;
Identify and process serious adverse events (saes) according to the procedures defined by the study team;
Demonstrate a broad understanding of the sae reporting process to regulatory authorities;
Liaise with data management to resolve data discrepancies and ensure all data management study goals are met;
Perform data management review, including in-house crf review, and alert pms and data managers to emerging issues with crf completion;
Prepare and perform site closeout visits according to the protocol, local laws, ich-gcp and gc cro’s sops;
Prepare accurate and timely visit reports from all types of visits;
May be involved in preparation of status reports for clients;
Conduct feasibility work;
Interact with internal work groups to evaluate needs, resources and timelines;
Initiate payment requests for investigators;
Perform other duties as assigned by management;
Travel as necessary according to project needs.
Your key working relationships: as the cra, you need to develop strong relationships with the following internal parties:
Clients and potential clients
Other cro members
Site management organisation (smo)/site research teams
Clinicians and kols
Undergraduate degree in life sciences (e.g., biology, chemistry, pharmaceuticals)
At least three years’ experience in monitoring clinical trials in cro (preferable), pharmaceutical and/or biotechnology industry as a cra/monitor.
Experience in edc & ctms
Experience in site selection
Experience in contracts negotiation desirable
Experience in hrec submission preparation
Understanding and practical knowledge of ich-gcp requirements particularly as required for site management.
Experience working in oncology and cardiology therapeutic areas highly preferable
Able to work in an international environment with internal & external team partners (including virtual teams) and asia pacific/european experience is highly desirable
Other requirements for this role:
Excellent communication skills, written and oral and good presentation skills
Excellent organisation and time management skills
Proactivity and risk management skills
Excellent computer skills
Undertake travel, domestically and internationally to fulfil the requirements of the role
#li-remote #li-ab1 who we are: we are 6000+ highly trained healthcare professionals and support staff across the united states, australia, the u.k, spain and china, designing cancer and heart disease treatments to help patients achieve the best possible life outcomesGlobal care across the world, we have more than 580+ centres to help us bring the right care to our patientsEvery year our team sees more than 1.4 million patients globally across our oncology, cardiology & sleep medicine centresPeople centricity is at the heart of what we do and we pride ourselves on making our people a priority, whether that be a patient or an employeeWe aim to build culture of ‘care’ that is patient focused, and performance drivenOur people promise is “do your life’s best work, by always growing, having a profound human impact and making great things happen together.” if you’d like to truly make a difference, join us at genesiscare! genesiscare is an equal opportunity employer.