Company: SynteractHCR Deutschland GmbH
Location: Carlsbad, CA
Closing Date: 12 Dec 16
Type: Full Time
Salary (£): On Application
Overview The Clinical Research Associate is responsible for the monitoring of clinical trials and tracking study progress, thereby contributing to the overall management of clinical trials in accordance with the standards of ICH-GCP and applicable local regulations and Standard Operating Procedures (SOPs). S/he is responsible for clinical study start-up, maintenance, and closure activities, including maintenance of study documents.
The Clinical Research Associate is responsible for the monitoring of clinical trials and tracking study progress, thereby contributing to the overall management of clinical trials in accordance with the standards of ICH-GCP and applicable local regulations and Standard Operating Procedures (SOPs). S/he is responsible for clinical study start-up, maintenance, and closure activities, including maintenance of study documents.
Interfaces with sponsor representatives and SynteractHCR study team to ensure timely initiation and completion of clinical trials.
Responsible for the identification, evaluation and qualification of investigators and sites.
Prepares initial regulatory document packages necessary for clinical site initiation.Collects and reviews regulatory documents received from clinical sites to ensure all required documents are obtained, complete and in compliance with GCP and local regulations.
May assist with the preparation, review and submission of all relevant regulatory documents to the appropriate Regulatory Authorities and IRB/IECs.
Maintains Trial Master File (TMF) and/or Investigator site files for the duration of the study ensuring essential documents are filed appropriately, and assisting in the file review and reconciliation process in preparation for audits and archival.
Maintains and updates project-related data in an existing database, i.e. CTMS, EDMS, etc.
Contributes to the development and revision of clinical documents (e.g. study manuals, plans and monitoring tools).
Reviews Patient Information Sheet /Informed Consent Forms (PIS/ICFs) and/or data protection authorizations as required.
Assists with the translation process of study documents.
Assists with feasibility studies.
Performs on-site monitoring of clinical studies through review of Case Report Forms (CRFs) and study records in order to report trends in safety, ensure timely reporting of Adverse Events and compliance with protocols, local regulations, and SOPs.Site visits and associated tasks are completed with oversight until authorized to be performed independently.
Documents monitoring activities in monitoring reports and follow-up letters.Responsible for communicating issues in a timely manner.
Responsible for site management.Duties include, but are not limited to, communicating directly with investigative sites to provide study direction, answer questions, assess recruitment rates and respond to sponsor requests.
Monitors and reports study progress/status on a site level.
Assists with processing of clinical investigator payments, study expense reports and other financial items.
Prepares or contributes to study related correspondence, including but not limited to: meeting minutes, tracking spreadsheets and the preparation of presentations
Assists in the planning, organizing and executing of project-specific meetings including, but not limited to, client meetings, CRA training meetings, and Investigator Meetings.
May represent SynteractHCR and Clinical Operations at study team meetings.May present at CRA Training Meetings and Investigator Meetings and may also assist with the organization of such meetings.
Prepares sites for audit by sponsor or inspections by FDA or other Competent Authorities; participates in internal audit preparation; assists with audit responses.
Performs training of site personnel.
Academic & Professional Qualifications:
Bachelor’s degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience.
Some applicable experience desired, but not essential.
Skills & Experience:
Working knowledge of ICH-GCP and state and local regulations, as applicable.
Keeps abreast of regulatory requirements and scientific knowledge and maintains technical expertise by reading relevant publications, attending courses and through membership in relevant professional associations.
Intermediate IT proficiency and skills including Microsoft Office.
What We Have to Offer
Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations
Who We Are
SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.
Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.
SynteractHCR’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with SynteractHCR must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.
SynteractHCR Deutschland GmbH
|Tel:||+49 89 12 66 80 0|
|Fax:||+49 89 12 66 80 2444|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.