Biotech Job:
All Biotech Jobs
inVentiv Health
Clinical Trial Associate
JOB SUMMARY
The Clinical Trial Assistant (CTA) supports clinical trial execution by performing specific operational tasks and supporting the RSM as appropriate. The CTA can work on several studies and with more than on RSM.
JOB RESPONSIBILITIES
1. Project Support responsibilities 30%
-Assist with regional site communications
-Assist with communications between the Study Team and Site Manager
-Ensure relevant site communications are sent to records management
-Support the distribution of IND Safety report
-Act as a point of contact for Site Managers
-Interact with sites and CROs as delegated
-Coordinate investigator meeting follow-up materials which need to be sent to the sites, if requested
-Coordinate with study file and regulatory for start up documentation and submit required docs (ID, protocols, list of sited, etc.).
-Prepare and send CDAs, Regulatory Packages, and other Study related materials
-Follow-up on regulatory approval status
-Answer audits
-Other activities as delegated by the RSM
2. Administrative Responsibilities 20%
-Respond to all inquiries or concerns coming from team members in a timely fashion.
-Communicate tracking update of performed duties regularly to team members.
-Read and respond diligently to internal and external correspondence.
-Submit all required reports duly completed and on time.
-Make certain that all confidential information is handled as per company SOP's.
-Ensure Wyeth SOP compliance.
-When requested the Global Trial Leader through the RSM, manage Investigator Meeting attendee list, travel arrangements and hotel accommodation in conjunction with Global Meeting Planner for his region.
-Coordinate investigator meeting follow-up materials which need to be sent to the
sites, if requested
-Continuously seek to innovate and always look for new ideas or opportunities for improvement in computer skills and applications, communication skills, and language skills
-Obtain training to expand knowledge of clinical research operations, Wyeth
procedures, and scientific areas.
3. Non-drug supplies tracking and shipping 25%
-Order CRF's, central lab supplies, and other study supplies
-Order central lab supplies and other study supplies
-Coordinate and send study documentation to sites (e.g. Investigator Brochure, Protocol, Financial Disclosure, etc.)
-Track CRFs books and re-order if necessary.
4. Enrollment tracking 15%
-Obtain regional enrollment reports weekly from global CTAs
-Compile a global enrollment status report
-As necessary, provide regular enrollment status updates to the study team
WORK FLOW
Studies are assigned by the RSM and CTA line management. Study work is performed in coordination with the RSM. The CTA will follow the Code of Federal Regulations (CFR), ICH/GCP guidelines, SOPs, SPIs, and Tip Sheets. Standard forms or templates will be used as appropriate.
DECISION MAKING
A. Describe the decisions generally made and indicate whether the incumbent is the final authority or participates in the decisions.
-Day to day operational and study/site management decisions will be made in consultation with the RSM.
-CTA is proactive in identifying and resolving issues and must demonstrate problem solving and decision making abilities with respect to clinical support issues.
The CTA receives training, mentoring and workload management from their line management. Instruction at the study-level comes from the RSM. CTA takes initiative to complete work with minimal supervision.
VII. INTERPERSONAL CONTACTS
A. Internal Contacts
a) RSM - Study activities and instruction - Daily
b) Site Manager - Study supply issues - As Needed
B. External Contacts
a) Investigators/Sites - As delegated by the RSM - As delegated
b) CROs - As delegated by the RSM - As delegated
PLANNING
What is the involvement with short and long range planning?
What organizational units does the incumbent plan for?
Follows the trial execution plan as outlined by the GTL and RSM
Conducts trial activities in accordance with timelines and in close collaboration with appropriate groups involved in the trial
Requirements:
BS/BA (Scientific preferred) + 4 or MA/MS + 2 years of clinical research experience or equivalent. Written and oral communications skills
Ability to mentor new CTA's. Computer Skills (MS Word, Excel, Powerpoint) Detail oriented. CFR and ICH/GCP familiarity. Knowledge of clinical trial management tasks
Apply:
For faster processing, please apply online and directly to the employer. Specific instructions on how to apply are available. (recommended)
Clinical Trial Associate
JOB SUMMARY
The Clinical Trial Assistant (CTA) supports clinical trial execution by performing specific operational tasks and supporting the RSM as appropriate. The CTA can work on several studies and with more than on RSM.
JOB RESPONSIBILITIES
1. Project Support responsibilities 30%
-Assist with regional site communications
-Assist with communications between the Study Team and Site Manager
-Ensure relevant site communications are sent to records management
-Support the distribution of IND Safety report
-Act as a point of contact for Site Managers
-Interact with sites and CROs as delegated
-Coordinate investigator meeting follow-up materials which need to be sent to the sites, if requested
-Coordinate with study file and regulatory for start up documentation and submit required docs (ID, protocols, list of sited, etc.).
-Prepare and send CDAs, Regulatory Packages, and other Study related materials
-Follow-up on regulatory approval status
-Answer audits
-Other activities as delegated by the RSM
2. Administrative Responsibilities 20%
-Respond to all inquiries or concerns coming from team members in a timely fashion.
-Communicate tracking update of performed duties regularly to team members.
-Read and respond diligently to internal and external correspondence.
-Submit all required reports duly completed and on time.
-Make certain that all confidential information is handled as per company SOP's.
-Ensure Wyeth SOP compliance.
-When requested the Global Trial Leader through the RSM, manage Investigator Meeting attendee list, travel arrangements and hotel accommodation in conjunction with Global Meeting Planner for his region.
-Coordinate investigator meeting follow-up materials which need to be sent to the
sites, if requested
-Continuously seek to innovate and always look for new ideas or opportunities for improvement in computer skills and applications, communication skills, and language skills
-Obtain training to expand knowledge of clinical research operations, Wyeth
procedures, and scientific areas.
3. Non-drug supplies tracking and shipping 25%
-Order CRF's, central lab supplies, and other study supplies
-Order central lab supplies and other study supplies
-Coordinate and send study documentation to sites (e.g. Investigator Brochure, Protocol, Financial Disclosure, etc.)
-Track CRFs books and re-order if necessary.
4. Enrollment tracking 15%
-Obtain regional enrollment reports weekly from global CTAs
-Compile a global enrollment status report
-As necessary, provide regular enrollment status updates to the study team
WORK FLOW
Studies are assigned by the RSM and CTA line management. Study work is performed in coordination with the RSM. The CTA will follow the Code of Federal Regulations (CFR), ICH/GCP guidelines, SOPs, SPIs, and Tip Sheets. Standard forms or templates will be used as appropriate.
DECISION MAKING
A. Describe the decisions generally made and indicate whether the incumbent is the final authority or participates in the decisions.
-Day to day operational and study/site management decisions will be made in consultation with the RSM.
-CTA is proactive in identifying and resolving issues and must demonstrate problem solving and decision making abilities with respect to clinical support issues.
The CTA receives training, mentoring and workload management from their line management. Instruction at the study-level comes from the RSM. CTA takes initiative to complete work with minimal supervision.
VII. INTERPERSONAL CONTACTS
A. Internal Contacts
a) RSM - Study activities and instruction - Daily
b) Site Manager - Study supply issues - As Needed
B. External Contacts
a) Investigators/Sites - As delegated by the RSM - As delegated
b) CROs - As delegated by the RSM - As delegated
PLANNING
What is the involvement with short and long range planning?
What organizational units does the incumbent plan for?
Follows the trial execution plan as outlined by the GTL and RSM
Conducts trial activities in accordance with timelines and in close collaboration with appropriate groups involved in the trial
Requirements:
BS/BA (Scientific preferred) + 4 or MA/MS + 2 years of clinical research experience or equivalent. Written and oral communications skills
Ability to mentor new CTA's. Computer Skills (MS Word, Excel, Powerpoint) Detail oriented. CFR and ICH/GCP familiarity. Knowledge of clinical trial management tasks
Apply:
For faster processing, please apply online and directly to the employer. Specific instructions on how to apply are available. (recommended)
Get Noticed