Pharm-Olam International Clinical Trial Associate in Houston, Texas
About Pharm-Olam International:
Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.
Acts as the focus for the project team administration and provides the Project Manager and all other project team members with advice, assistance and support, as required, thus ensuring that the clinical trial is conducted in accordance with international regulatory and ethical guidelines for Good Clinical Practice and Standard Operating Procedures. Assists the study team with the day-to-day conduct of international clinical studies.
Assists CRAs, Lead CRAs (LCRA), Clinical Team Leaders (CTL) and Project Managers (PM) with the day-to-day administrations of clinical studies.
Tracks critical documents and informs PM / CTL and/or LCRA of outstanding documents.
Accurately updates and maintains clinical systems within project timelines.
Prepares, distributes, files, and archives clinical documentation Reviews study files periodically for accuracy and completeness.
Prepares and distributes clinical trial supplies and maintenance of tracking information.
Assists PM / CTL / LCRA / CRAs with collection and filing of critical documents and documentation required for submission to Regulatory Authorities and Ethical Committees.
May act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
Performs administrative tasks to support team members with clinical trial execution, as required.
Provides training and mentoring, as required, on Pharm-Olam procedures and clinical trial administration. Resolves logistical and practical issues.
Prepares Trial Master File according to Pharm-Olam's SOPs.
Reviews study related Trial Master File documentation to ensure compliance with SOPs and ICH-GCP on an ongoing basis, and before audit, inspection, or return of files to a Sponsor.
Follows up study team or Sponsor requests for clarifications, supplementary information.
Assists PM with generation of study specific forms for Investigator Site Files.
Attends Investigator and CRA meetings. Records questions and answers, and coordinates with the hotel staff to ensure smooth running of the meeting.
Attends clinical teleconferences, and prepares and distributes minutes for Sponsor and Project Teams within agreed timelines.
Prepares Investigator Site Files, Investigator Manuals and Training Manuals.
Manages returning/archiving study files.
Generates and reviews management reports from internal tracking systems at requested intervals.
Communicates with sites regarding trial start-up, conduct, and close-out activities at requested intervals, if needed.
May participate in feasibility and/or site identification activities.
Assists in resolution of logistical and practical issues on project and clinical trial administration processes.
Reports to Clinical Trials Associate Manager, COM or designee
Collaborates with project teams and all Pharm-Olam staff
Communicates with Sponsor and sub-contractors if requested by Project Manager
Collaborates with Training Department, as needed
Experience of at least 2 years within a similar role or as a clinical research coordinator
All requirements of Clinical Trial Associate II
Fluency in English (spoken and written)
Customer service orientation
Sound knowledge of medical terminology and clinical monitoring process
Strong verbal and written communication skills
Computer literacy, proficiency in Microsoft Office
Excellent interpersonal and organizational skills
Ability to work independently and to effectively prioritize tasks
Ability to manage multiple projects
Attention to detail
Good presentation skills
Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and vendors
For Consideration: Please forward resume and salary requirements for confidential consideration via email at email@example.com or fax to (832) 202-0564. Due to the number of inquiries, we are unable to respond to each inquiry. Candidates of interest, matching the above qualifications will be contacted for further consideration.
PRINCIPALS ONLY, NO PHONE CALLS PLEASE.