Senior Clinical Research Associate (FSP) - Home based England

ExecuPharm a PAREXEL company is a contract research organization (CRO) that provides clinical research support services to companies from the pharmaceutical industry. We are currently hiring a new Site Activation Partner to be assigned to one of our prestigious Biopharmaceutical sponsors in Mumbai.

The company has more than 18,000 global clinical operational specialists in its network and it is one largest privately-owned global diversity suppliers of clinical development services since 1994.

Position Purpose:

This position provides oversight of clinical research sites compliance with ICH/Good Clinical Practices (GCP), governing SOPs (standard operating procedures) and clinical study protocols.

Organizational Relationships:Reports to EP assigned Clinical Operations ManagerInterfaces with cross-functional study team members in a matrix environment (i.e. data management)

Primary Duties:Serves as the primary monitoring point of contact for assigned clinical research sitesPerforms site development and training (supporting and coaching site personnel), site set-up, site monitoring (evaluation of site performance and identification of issues), and site close-out activities for assigned clinical research sites with designated program SOPs, Client expectations, clinical study protocols and GCPsProblem solves (including CAPA development where necessary) identified issues with appropriate escalation to sponsor CSM or Clinical Operations Manager and/or designeesAssures protection of the rights, safety, and well-being of subjects, study integrity and data qualityPerforms activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, device accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolutionFacilitates the collection and maintenance of regulatory and site documentation for the Trial Master File and site fileManages Central and Local IRB or EC submissions including; workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB or EC in conjunction with study team/Client/site staff as applicable.Maintains awareness of site dynamics and able to motivate, persuade and educate site staffComplies with the Clinical Monitoring Plan and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the studies within the programCompletes monitoring reports in compliance with requirements in the Clinical Monitoring PlanCompletes training assigned by ExecuPharm/PAREXEL as applicable and/or the Client, as necessary, including general training requirements, SOPs, and system and process related training, and protocol specific training.Exhibits ability to proactively identify and interpret problems, recommend creative solutions, and influence appropriate changesMay support more than one study, as requiredComplies with all objectives and metrics related to study and program executionAttend meetings as requested (i.e. investigator, study, program) to gain and/or share program/study/site knowledgeIf applicable to the CRA region, the CRA needs to speak and write the local language to be able to write/respond/assist with EC submissions/questions as directed by the CSM and as needed by sponsorQualificationsMore about you

On your first day we’ll expect you to have:A Bachelor’s degree required, degree in life science/medical background preferred. Equivalent workexpertise is accepted.A Minimum 5 years of monitoring experience1 year medical device experience in Orthopedic, Sports Medicine, or Wound care preferredMediData RAVE, EC submission experience preferredDemonstrates solid understanding of clinical research practicesWorking knowledge of GCPs and other regulations governing clinical researchA self-motivated approach to working in an independent environmentEffective oral and written communication skillsAbility to travel as required to meet program objectives

A little about us

Parexel is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you’ll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology “super user” or collaborator are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level CRA role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees.