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Clinical Research Associate
2 months ago
Job DetailsJob LocationMain Corporate Office - Malvern, PADescriptionJob PurposeThe Clinical Research Associate is a key member of Ocugen's clinical trial management team and integral to the successful planning and execution of clinical studies. This individual will develop and maintain strong, productive relationships with both the clinical sites and CRO and is responsible for the oversight of clinical monitoring activities.Duties and Responsibilities:Support study management team to ensure that studies are conducted in adherence to study protocols, applicable SOPs, ICH/GCP guidelines and government regulationsAssist study team(s) in the identification, feasibility assessment, qualification, and selection of clinical research sitesDrives the study start-up process in conjunction with the CRO ensuring timely submission of regulatory documents and completion of clinical trial agreements and budgetsInterface with clinical sites to ensure timely and accurate completion of study tasks including entry of study data and resolution of data queriesInterface with CRAs/CRO monitors ensuring CRA training, execution and reporting of monitoring visits and follow up on monitoring visit action itemsDrive recruitment/retention follow-up with clinical study sites to support and achieve enrollment goalsProactively identifies risks, developing and implementing mitigation plans as applicableDraft or assist with preparation of study-related documents, tools and templatesProvides oversight of TMF including compliance with the TMF plan and TMF reconciliationLiaises with CMC and vendors to ensure management of study drug supply including tracking and issue resolutionParticipate in study and department meetings. Prepares agendas and minutes and maintains key decision and action item logsMay assist study team and department with financial tracking and reporting which may include coordination of CRO, vendor, and site contractsMay assist in developing policies and procedures (SOPs)Additional tasks and projects as requestedQualificationsBA/BS degree, preferably in life sciences3+ years of progressive clinical research experience in the biotechnology/pharmaceutical industryExperience in ophthalmology or vaccine studies in Phases 1-3 is a plusStrong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studiesDemonstrated attention to detail and outstanding organization skillsSelf-motivated with a commitment to high quality, on-time deliverablesExcellent communication and collaboration skills with a team-oriented approachExperience with eTMF, CTMS and EDCDemonstrated ability to identify and resolve issues and effectively manage timelinesWorking ConditionsThis position operates in an office setting and may include 50% of travel to visit sites, vendors or CROs. Job may require incumbent to be available outside of these hours to handle priority business needs.Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past,current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
