高级临床研究助理 - 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 requestedConduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirementsFunction in the role of Lead CRA for global studies, coordinating CRAsDevelop Clinical Monitoring Plan as requestedConduct site visit trip report review and provide feedback and editsProvide mentoring and guidance to less experienced CRAs and site staff when neededDesign study specific tools and templates as requestedActively participate in study team and investigator meetingsActively participate in bid defensesCreate and conduct training to study team members or colleagues as requested and appropriateWork with Project Management to evaluate deliverables and study milestonesCompile 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 siteDocument site visit findings via written reportsProvide input into the design of protocols and CRFs as requestedAssess, monitor, and train study site staff on protocol adherence as requiredReview study subject safety information and informed consentConduct source document verification for compliance, patient safety, and veracity of dataReview CRFs using paper or electronic data capture systems and assist sites with data query resolutionAssist the site in maintenance of the Investigator Site FileMaintain regular communication with sitesProvide applicable updates for site related documentation for filing in the Trial Master File (TMF)Ensure site compliance with IP receipt, accountability and return or destructionConduct accompanied site visits for assessment or training of other CRAs as requested and appropriateComplete 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 skillsExcellent planning and organizational skills with effective time managementExcellent interpersonal skillsDemonstrate initiative and problem solving skillsAbility 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 activitiesExtensive understanding of clinical research principles and processThorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirementsThorough understanding of two to three therapeutic areas sufficient to function as a Lead CRA as appropriateThorough understanding of standard operating proceduresProficiency in Microsoft OfficeProficiency 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 ORA 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, ORTwo-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree preferred) and a minimum seven years as a Clinical Research AssociateWillingness to travel requiredValid current passport requiredDriving license requiredFluent 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 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, and successful. 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.
Originally posted on Himalayas