Job Description

Senior Clinical Research Associate (12-month renewable contract)

Therapeutic Area: Oncology

*Must be open to domestic travel*

Essential tasks include but are not limited to:

• Independently oversees all aspects of study site management to ensure patient safety is protected,

quality of data generated by managed sites resulting in consistently low query levels and in acceptable

Quality Assurance reports.

• Provides guidance at the site and project level towards audit readiness standards and supports

preparation for audit and required follow-up actions.

• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status

reports.

• Manages site start up procedures including the feasibility and recruitment of potential investigators,

preparation of EC/IRB submissions, collection and review of regulatory documents, review and

adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as

appropriate, translation of study related documentation, organization of meetings and other tasks as

instructed by the Clinical Trial Manager/Project Manager.

• If required, assists the negotiation of study budgets and the execution of investigator contracts under

directions of Site Contract Management department/designee.

• Verifies the process of obtaining informed consent has been adequately performed and documented for

each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety

and clinical data integrity at an investigator/physician site such as protocol deviation/violations and

pharmacovigilance issues.

• Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine

monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and SOPs.

Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits for

review, accurate and timely monitoring reports from all site visits (on-site and remote).

• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and

other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and

client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters

data into tracking systems as required to track all observations, ongoing status and assigned action

items to resolution.

• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles

contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of

the requirement of archiving essential documents in accordance with local guidelines and regulations.

• Communicates effectively and proactively with both site personnel and Project and Clinical Trial

Management to relay protocol/study issues including any deviations and implements necessary actions

in response to those issues.

• Develops and maintains good working relationship with investigators and study staff.

• Performs investigational product (IP) inventory, reconciliation and reviews storage and security.

Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.

Verifies issues or risks associated with blinded or randomized information related to IP. Applies

knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately

(re)labelled, imported and released/returned.

• Performs data review activities, including remote EDC CRF and patient profiles review, query

resolution, and assists data management and clinical data quality personnel to resolve data

discrepancies.

• Identifies and processes Serious Adverse Events according to the procedures defined by the study

team. Also demonstrates a full understanding of the SAE reporting process.

• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested

contingencies. Owns the timely and appropriate resolution of the risk with oversight from project

team.

• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. attends

clinical training sessions according to the project specific requirements. May prepare or assist in

preparation of study-specific presentations/training materials and tools.

• Assists the team managers in the preparation and review of protocols and other study documentation

as instructed

• Supports the design and development of CRFs and clinical trial documents as they pertain to clinical

monitoring activities (i.e. operating manuals, monitoring guidelines, etc.).

• Assists with review of clinical study reports.

• Interacts with client, participates in proposal activities, including development and client presentations

as instructed

• Initiates payment requests for investigators.

• Travels as necessary according to project needs.

• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Europe: University degree life science/pharmacy/other health related discipline or equivalent

experience in a scientific or healthcare discipline or be a licensed health care professional.

• N. America: 4-year college degree or equivalent experience in a scientific or healthcare discipline

• 3.5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent,

relevant experience and/or demonstrated competencies. Significant site management experience or

equivalent experience in clinical research

Preferred:

• Graduate, postgraduate degree

• Experience monitoring in rare and complex therapeutic areas

• Experience monitoring EDC trials and EHR records

• Experience in biopharma or relevant therapeutic area

• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular

country

• Ability to monitor study sites according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines

• Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from

management

Job Tags

Similar Jobs