Sr. Contract Clinical Research Associate

Company: Aerotek
Location: Raleigh
Posted on: April 10, 2021

Job Description:

Description:The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencingAble to work within remote teams andAbility to effectively manage multiple priorities and responsibilities of increasing scope and complexity.Good interpersonalStrong planning & organizational skills, and the ability to work efficiently and effectively in a dynamicRespects confidentiality in terms ofProactive, conscientious and precise in delivery of quality work even when under pressureEffective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timelyFlexible with high learning and change agilityCollaborative, building strong internal and externalAvailable and willing to travel as job requiresStrong computer skills with good eye forPerforms site evaluation visits:Determines the feasibility of the study protocol with reference to study complexityConfirms staff availability, suitable clinical facilities, potential for per protocol patient population,Confirms ability to comply with ICH GCP and requirements for clinical studies.Works with Study staff to carry out a local study / site level riskDelivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinicalParticipate in global investigators and/or monitor meetings as appropriate. Facilitates investigator's participation in global meetings and/or may assist the study staff with organizing local investigator Participates in other study meetings as required.Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones areEnsure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP).Work with the sites to ensure they address data queries in a timely Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time.Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to safety department and other relevant departments, within the required time frames.Completes monitoring visit reports within the agreedEnsure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS).Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately.Ensure sponsor study records are inspection ready at all times and archives records as applicable.Skills:Clinical research, oncology, craTop Skills Details:OncologyCRA Site Manager Clinical Research AssociateAdditional Skills & Qualifications:2+ years of clinical monitoring experience required. Knowledge of ICH and local regulatory authority regulations regarding drug Ability to travelExperience in monitoring all trial components (PSSV to COV)Experience in coaching/mentoring other CRAsExperience Level:Entry Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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