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Department:Clinical Operations

No. of Positions: 2

United States:California, New Jersey, Illinois or Massachusetts

Europe:Spain, Netherlands, Ireland or United Kingdom (Remote)

LCRA/A.CTM is responsible for managing the development, coordination and implementation of site management and clinical monitoring responsibilities for assigned protocols with guidance from the Clinical Operations Lead. Provides expertise in clinical monitoring services for all phases of clinical studies.Will provide support to COL and PMs on clinical operational aspects to for the assigned global clinical trial(s) from preparation until closure.

1) Key responsibilities:

• Supports the clinical team, especially the Clinical Operations Lead and PM(s), in overseeing clinical monitoring and operational study execution of assigned protocol.
• Initiates, coordinates, and manages Clinical Research Associates (CRAs) teleconferences.
• Creates, maintains, and reports metrics for monitoring study visit reports and study data.
• Ensures all CRA monitoring is performed on time, per GCP, and that trip reports are completed and reviewed on time and per the monitoring plan.
• Act as a first line of contact for CRAs for study specific issues and questions.
• May assist in the design and development of study related documents including (but not limited to) monitoring guidelines, monitoring plans, CRA evaluation plans, Informed Consent Form templates, Case Report Forms, CRF guidelines/instructions, Data Management Plans, source document templates, monitoring visit report templates, site tools and worksheets.
• Assist in the review and tracking of regulatory document and other study related documents.
• Conducts all types of monitoring, co-monitoring, CRA evaluations visits at study sites as required, including pre-study evaluations (international visits). Provides feedback for evaluation by the Clinical Operations group / or designee.
• Writes trip reports or evaluation reports and follow-up letters as required. Also responsible for the tracking of all study visits and reports and make sure they are consistent with the monitoring plan.
• Reviewing monitoring visit reports, protocol deviations and data listings to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns.
• Pro-actively identifying and solving issues in the assigned clinical trial(s) and timely escalating them to the COL, PM, Director of ClinOps or Senior Management, if needed.
• Interface with individuals in other functional areas to address study needs.
• Contribute to the review of protocols and other study documents. Performs data review, query generation and query resolution.
• Participates in meetings and conference calls with internal project teams and external partners.
• Participates in the training of vendors. May be required to train site staff on protocol specific issues, GCPs or other necessary training.
• Identifies deficiencies and coordinates training for CRAs.
• May be responsible for the review and approval of time sheets and expense reports for CRAs. Must ensure consistency with contract and travel policy.
• Assist in the development and review of standard operation procedures (SOP) and working practices.
• Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays.
• Communicating in a transparent, clear way and motivating team members to work towards achieving clinical trial goals.

2) Work relations:

• Project, functional and administrative reporting to Manager, Clinical Operations.
• Interfaces with site monitoring team, site personnel, HR, site in-charge and administration executive.

3) Key success factors:

• Timely and qualitative site monitoring activities
• Compliance to turnaround times and quality reports
• No major findings in internal or external audits.
• Timely issues identification and resolution
• Study recruitment as per recruitment plan

4) Qualifications:

• Graduate / post-graduate in scientific discipline or health care preferred.

5) Experience:

• 4+ years of prior experience in conducting site monitoring and trial management.
• Deep understanding of clinical development within all trial phases (I, II, III, IV) and a working understanding of cross functional drug development.

6) Skills:

• Knowledge of ICH GCP and applicable clinical trial regulations and guidelines.
• Effective verbal and written communication skills
• Experience with tools and systems for managing clinical trials
• Ability to work amidst demanding timelines

Department:Clinical Operations

No. of Positions:2

United States:California, New Jersey, Illinois or Massachusetts

Europe:Spain, Netherlands, Ireland or United Kingdom (Remote)

1) Key responsibilities:

• Responsible for managing the development, coordination and implementation of site management and clinical monitoring responsibilities for assigned protocols with guidance from the Clinical Study Manager. Provide expertise in clinical monitoring services for all phases of clinical studies.

 

• Supports the clinical team, especially the Clinical Study Manager, in overseeing clinical monitoring and operational study execution of assigned protocol per Sponsor and SOW.
• Initiates, coordinates and manages Regional Clinical Research Associates (CRAs) teleconferences (weekly or as needed).
• Creates, maintains and reports metrics for monitoring study visit reports and study data.
• Ensures all CRA monitoring is performed on time, per GCP, and that trip reports are completed and reviewed on time and per the monitoring plan.
• Acts as the first line of contact for Regional CRAs for study specific issues and questions. 
• May assist in the design and development of study related documents including (but not limited to) monitoring guidelines, monitoring plans, CRA evaluation plans, Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plans, source document templates, monitoring visit report templates, site tools and worksheets.
• Assist in the review and tracking of regulatory documents and other study related documents.
• Conducts all types of monitoring, co-monitoring, CRA evaluations at study sites as required.  Provides visit feedback for evaluation by the Clinical Operations group/or designee.
• Writes monitoring visit reports or evaluation reports and follow-up letters as required by SOPs for study visits.  Also responsible for the tracking of all study visits and reports and make sure they are consistent with the monitoring plan.
• Interface with individuals in other functional areas to address study needs.
• Assists in the review of required documents for Clinical Trial Material (CTM) release authorization.
• Contributes to the review of protocols and other study documents. Performs data review, query generation and query resolution.

 

• Participates in meetings and conference calls with internal project teams and external partners.
• Participates in the training of vendors and study coordinators on study requirements.  May be required to train site staff on protocol specific issues, GCPs or other necessary training.
• Identifies deficiencies and coordinates training for CRAs.
• May be responsible for the review and approval of time sheets and expense reports for CRAs. Must ensure consistency with contract and travel policy.
• Assist in the development and review of standard operating procedures (SOP) and working practices (WP).
• Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
• Any other roles and responsibilities delegated by the organization.

2) Key success factors:

• Timely and qualitative maintenance of the trial master file.
• Timely reporting to the supervisor or line manager.
• Compliance with CliniRx quality standards.
• Timely completion of assigned trainings.
• Gain an adequate understanding of applicable regulations, guidelines, and SOPs and
• timely and qualitative delivery of in-house documentation.
• Timely completion of activities as assigned by the supervisor or line manager.
• Timely and qualitative study monitoring activities.
• Timely report generation and submission.

3) Qualifications:

• Graduation or post-graduate in a scientific discipline or health care preferred.

4) Experience:

• Must have at least 5 years direct CRA experience at a pharmaceutical company and/or CRO.
• Must have at least 1-year experience managing CRAs.
• Solid experience in field monitoring (clinical trials) as a CRA or as a Senior CRA.

5) Skill:

• Excellent verbal, written communication skills and interpersonal and presentation skills are required.
• Excellent keyboard skills, with experience using Microsoft Office (Outlook, Word, Excel and Power Point) applications to prepare charts, tables, forms, reports and presentations required.  Experience with email and calendar programs necessary
• Electronic data capture (EDC) experience required and CTMS and IVRS system experience is a plus.

 

• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.
• Strong problem solving, organizational and time management skills.
• Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals.
• Must have a general understanding of routine project goals from an organizational perspective.
• Ability to prioritize and plan workload is essential.

Department:Clinical Operations

No. of Positions:2

United States:California, New Jersey, Illinois or Massachusetts

Europe:Spain, Netherlands, Ireland or United Kingdom (Remote)

1) Primary Purpose:

• To ensure timely and qualitative delivery of site monitoring activities as per the site monitoring plan.

2) Major accountabilities:

• Deliver on the site monitoring plan by gaining adequate understanding of the SMMP, protocol and project plan such that the quality and timelines of the monitoring plans are adhered.
• Ensure sites are managed as per SMMP and applicable regulations/ norms, so as to ensure QA audits observations are minimized.
• Assist in identification of new potential sites across therapeutic area
• Continuously upgrade technical as well as soft skills and translate them into superior performance.

3) Key responsibilities:

• Conduct of pre-site visits
• Responsible for site initiation, monitoring and closeout activities and preparation of reports for activities conducted in accordance with SOPs and SMMP
• Responsible for training of team at site for start up activities & site initiation.
  Collection of essential documents from sites.
• Checking the Site Master File for completeness and updated status, including updates on Investigator Undertaking and Delegation of Duties log.
• Will perform Source Document Verification (SDV) per Monitoring Plan. Will verify that source documents and other trial records are accurate, complete, kept up-to-date and maintained according to applicable SOPs. Discrepancies identified on SDV should be discussed with the relevant investigator(s) and corrected and documented appropriately.
• Will ensure inclusion / exclusion criteria are being followed and the drug is being dispensed per protocol to eligible subjects.
• Will ensure that investigator has reported all SAEs in accordance with protocol and regulatory requirements
• Will review all the ICFs (100 % subjects) for accuracy and completeness.
• Will ensure that eCRFs are completed from the sites as specified in the protocol and/or Monitoring Plan.
• Will facilitate obtaining resolution to Data queries from the sites / Queries resolved in the eCRF.
• Will ensure that the investigator follows the approved protocol and all approved amendment(s), if any.
• Will ensure that drug supplies are stored in a secure location, at acceptable conditions
• Will verify that copies of Status Reports submitted by CliniRx / Sponsor are filed in the Site Master File.
• The CRA will be responsible to resolve the QA findings at the assigned sites, within given timelines

4) Work relations:

• Project, functional and administrative reporting to Manager, Clinical Operations.
• Interfaces with site monitoring team, site personnel, HR, site in-charge and administration executive.

5) Key success factors:

• Timely and qualitative site monitoring activities
• Timely report generation and submission

6) Qualifications:

• Science graduate / Post graduate

7) Experience:

• 1-4 years of prior experience in conducting site monitoring

8) Skill:

• Deep understanding of ICH GCP and applicable clinical trial regulations and guidelines.
• Effective verbal and written communication skills, multitasking ability, persuasive, ability to work amidst demanding timelines.

Department:Regulatory Affairs

No. of Positions:2

United States:California, New Jersey, Illinois or Massachusetts

Europe:Spain, Netherlands, or United Kingdom (Remote)