Softworld, Inc. Information Technology Services
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http://www.softworldtech.com
http://www.softworldtech.com
USD
45
55
HOUR
true
Job Title: 80998 - Base Site Managers
Job Location: New Brunswick NJ 08901
Onsite Requirements:
Job Description:
Deliverables:
Entry (Level 0) / Base (Level 1):
Level 1 (Base):
Education and Experience Requirements:
Base Site Managers
Posted: 11/25/2024
2024-11-25
2025-01-01
Employment Type:
Contract
Industry: IT
Job Number: BBBH80998_1732573386
Pay Rate: US$45 - US$55 per hour
Job Description
Job Title: 80998 - Base Site Managers
Job Location: New Brunswick NJ 08901
Onsite Requirements:
- Therapeutic Area - Oncology
- 2 years monitoring experience
- Able to travel regionally 8 days per month
Job Description:
- Site Management services provide Trial Co-ordination and Site Management services as primary point of contact between the sponsor and the investigational site.
- Services/deliverables include ensuring trial sites are inspection ready through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), applicable regulations from start-up through data-base lock.
- Further, services/deliverables will include pretrial assessment, site selection, subject recruitment and retention planning, site initiation, monitoring and close-out.
- Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Local Trial Manager (LTM) and Central Trial Manager (CTM)/Global Trial Manager (GTM) to ensure overall site management while performing trial related activities for assigned protocols.
Deliverables:
Entry (Level 0) / Base (Level 1):
- Level 0 (Entry) can perform all the site management services as level 1 under guidance with a reduced
- site load and enhanced oversight.
- Services rendered will adhere to applicable Client SOPs, WIs, policies, local regulatory
- requirements, ICH-GCP, etc.
- Complies with relevant training requirements.
- Contribute to quality Site Selection through participation in site feasibility and/or pre-trial site
- assessment visits, providing recommendation from local area about site/investigator selection in
- collaboration with the trial team, as required.
- Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff
- throughout the life of the trial (investigator meetings, site visits, quality communication, etc.).
- Drive study compliance by executing activities within site initiation and start-up, site monitoring, site
- management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
- Ensures site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases.
- Contribute to site level recruitment strategy and contingency planning and implementation in
- partnership with other functional areas to achieve clinical research targets.
- Ensures site is equipped to carry out the trial with adequate site study supplies (such as Non-IP, lab
- kits, etc.) and clinical drug supplies.
- This will include oversight of proper handling, storage and return and/or destruction with accurate inventory maintained/documented.
- Ensures quality data (accurate, valid and complete) is provided by the site and queries resolved
- within expected timelines.
- Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting
- timelines and documented as appropriate, with supporting data collected and verifiable with
- information in the source documents
- Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and
- essential documents in systems utilized for trial management (e.G. CTMS and eTMF/IF) according to
- expectations (metrics) and archiving retention requirements, including storage in a secure area at
- all times.
- Focuses on Investigator engagement through timely follow up with sites.
- Completes follow-up letter to communicate relevant information and required corrective action to the investigator and his/her team within 15 working days of monitoring visit. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Follows the corresponding Monitoring Guidelines for each assigned trial.
- Collaborates with LTM for documenting and communicating site/study progress and issues to trial
- central team.
- Keeps oneself inspection ready and knowledgeable for current work by complying with relevant
- training requirements and developing therapeutic knowledge sufficient for role and responsibilities.
- Works closely with LTM to ensure CAPA is completed for QA site audits and for quality issues
- identified at the site during routine monitoring and other visit types, e.G. On Site Quality
- Monitoring Visit (OSQMV).
- If applicable, will support negotiation of investigator budgets at site level, support tracking of costs
- and ensure payments are made at site level, maintaining site relationships.
- May participate in the HA and IEC/IRB submission and notification processes as
- required/appropriate.
- May contribute as a mentor to a less experienced site manager or to process improvement and
- training, as appropriate for business needs (mostly for level 1).
- Ensure timely and accurate CTMS data entries / updates.
- SMs may also take the role of Independent Drug Monitor (IDM) once additional training is
- completed and as required by individual trial.
- If applicable, region-specific deliverables will be specified.
Level 1 (Base):
- 2 years of clinical trial monitoring experience or equivalent industry
- experience and/or provider specific academy completion and completion of a monitoring training course
Education and Experience Requirements:
- BA/BS degree/Degree in a health or science related field or equivalent industry experience
- Specific therapeutic area experience depending on the services need.
- Working knowledge of ICH GCP, company standard operating procedures, local laws and
- regulations, assigned protocols and associated protocol specific procedures including monitoring
- Demonstrate proficiency in IT skills for appropriate software and company systems.
- A willingness to travel overnight stay away from home according to business needs.
- Proficient in speaking and writing in English and the country language where services will be provided.
- Effective communication skills, oral and written.
- Experience with monitoring and site management of complex Early Phase of clinical development, as applicable
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