Senior Clinical Research Associate - SK
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
*SUMMARY: **Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.**RESPONSIBILITIES:*
_Tasks may include but are not limited to:_
Perform feasibility studies for potential sites as requested
Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
Function in the role of Lead CRA for global studies, coordinating CRAs
Develop Clinical Monitoring Plan as requested
Conduct site visit trip report review and provide feedback and edits
Provide mentoring and guidance to less experienced CRAs and site staff when needed
Design study specific tools and templates as requested
Actively participate in study team and investigator meetings
Actively participate in bid defenses
Create and conduct training to study team members or colleagues as requested and appropriate
Work with Project Management to evaluate deliverables and study milestones
Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
Document site visit findings via written reports
Provide input into the design of protocols and CRFs as requested
Assess, monitor, and train study site staff on protocol adherence as required
Review study subject safety information and informed consent
Conduct source document verification for compliance, patient safety, and veracity of data
Review CRFs using paper or electronic data capture systems and assist sites with data query resolution
Assist the site in maintenance of the Investigator Site File
Maintain regular communication with sites
Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
Ensure site compliance with IP receipt, accountability and return or destruction
Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate
Complete final site close out visit and report
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
*OTHER SKILLS AND ABILITIES: *
Excellent oral and written communication skills
Excellent planning and organizational skills with effective time management
Excellent interpersonal skills
Demonstrate initiative and problem solving skills
Ability to lead and motivate assigned team (if applicable)
Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
Extensive understanding of clinical research principles and process
Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
Thorough understanding of two to three therapeutic areas sufficient to function as a Lead CRA as appropriate
Thorough understanding of standard operating procedures
Proficiency in Microsoft Office
Proficiency with IxRS, EDC systems
*REQUIREMENTS:*
Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc. ) and with a minimum experience of three years as a Clinical Research Associate OR
A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science and a minimum experience of five years as a Clinical Research Associate, OR
Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree preferred) and a minimum seven years as a Clinical Research Associate
Willingness to travel required
Valid current passport required
Driving license required
Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, andsuccessful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law .