Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
Assesses site processes, conducts Source Document Review, verifies required clinical data entered in the case report form (CRF) is accurate and complete.
Applies query resolution techniques remotely and on site, driving query resolution to closure within agreed timelines.
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
Requirements
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Supervises the work of laboratory personnel engaged in performing routine and specialized technical procedures, including planning day to day laboratory work activities, evaluating work performed and handling procedural technical and non-technical laboratory problems.
Compensation
Base Pay Scale: Generally starting at $66.52 - $88.14 per hour
Responsibilities
Supervises laboratory personnel engaged in performing routine and specialized technical procedures.
Plans the daily lab operations, evaluates work performed, assists in troubleshooting and provides direction in handling procedural and technical problems.
Develops appropriate work schedules for employees and plans daily work assignments to maintain adequate staffing, minimize overtime, and meet customer service needs.
Under the guidance of the section Medical director, develops and implements department specific processes/procedures and quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment, and compliance to safety/health and state/federal/licensing regulations.
Ensures section compliance with all applicable regulations and guidelines (CAP, JCAHO,state, federal and SHC).
Requirements
Bachelor's degree in a work-related discipline/field from an accredited college or university
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
Assesses site processes, conducts source document review, verifies required clinical data entered in the case report form (CRF) is accurate and complete.
Applies query resolution techniques remotely and on site, driving query resolution to closure within agreed timelines.
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
Support global communication activities and keep essential processes running smoothly for Bosch Mobility’s global Digital Strategy & Execution team.
Compensation
Flexible benefits system – In addition to your salary, we provide 2700 RON/year through your benefits account, allowing reimbursements based on your preferences; Meal tickets - A balanced diet includes at least one hot meal per day, therefore we offer you meal tickets with a value of 40 Ron; The company performance related pay - Your contribution to Bosch is valuable. Celebrate a successful year with the company performance related pay; Celebrate together - We Like to give presents to our Loved ones, therefore we offer you 300 Ron for Christmas and Easter. Your minor children will enjoy this benefit too, as they will also receive 300 Ron; Loyalty bonus: We value your commitment and at 5 years you will receive 750 RON, at 10 years 1500 RON, and for every additional 5 years brings another 1500 RON. It’s our way of saying thank you for being part of our journey; Language courses - A new language is key to a new world, so we invite you to learn languages in your free time and get a discount of up to 1200 RON/year (e.g.: two modules of 600 RON each). Please note that the discount is based on the certification that you have passed the specific module; Referral bonuses - We build our teams on trust, so we encourage you to refer new candidates to us through our program: Recommend Bosch. For certain positions, we will honor you with an attractive bonus; Relocation package - If you’re being recruited from more than 50 km away, we provide a standard relocation package of 2500 RON (conditions apply). This is a one-time fee, paid together with your first salary; Life events celebration - Your family is growing while working at Bosch? We congratulate your newborn with a 5000 RON bonus; Unforeseen situations - In case of unfortunate events, we support you by offering you free days and financial support (handled on a case-by-case basis); Discounts to our partners - We have a strong network in our community so we can offer you discounts to various businesses such as ISHO, Vodafone, and others.
Responsibilities
Coordinate leadership meetings, business travel, workshops and events
Maintain intranet content and communication distribution lists
Generate compliance and status reports
Manage access rights for team-related folders and systems
Approve and coordinate IT role assignments
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