LEVANZO

The Clinical Research Associate (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. Looking for Ideally Oncology experienced CRAs but willing to train anyone that doesn't have Oncology.

Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing

Able to work within remote teams and

Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.

Good interpersonal

Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic

Respects confidentiality in terms of

Proactive, conscientious and precise in delivery of quality work even when under pressure

Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely

Flexible with high learning and change agility

Collaborative, building strong internal and external

Available and willing to travel as job requires

Strong computer skills with good eye for

Performs site evaluation visits:

Determines the feasibility of the study protocol with reference to study complexity

Confirms staff availability, suitable clinical facilities, potential for per protocol patient population,

Confirms ability to comply with ICH GCP and requirements for clinical studies.

Works with Study staff to carry out a local study / site level risk

Delivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical

Participate in global investigators and/or monitor meetings as appropriate. Facilitates investigator’s participation in global meetings and/or may assist the study staff with organizing local investigator Participates in other study meetings as required.

Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are

Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP).

Work with the sites to ensure they address data queries in a timely Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time.

Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.

Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to safety department and other relevant departments, within the required time frames.

Completes monitoring visit reports within the agreed

Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS).

Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately.

Ensure sponsor study records are inspection ready at all times and archives records as applicable.

The Senior Contract CRA will monitor clinical trials, either at the site or remotely, to ensure the studies are conducted in accordance with the protocol, SOP’s, ICH-GCP and all applicable regulatory requirements. You will be deployed to our client, a large CRO with a strong therapeutic expertise in oncology & immuno-oncology, on a contractual basis.

Experience requirements include, but are not limited to:

• 5+ years of monitoring experience

• Ability and willingness to travel

• Demonstrated and extensive Oncology monitoring

• Immuno-Oncology experience preferred

• Knowledge of ICH and local regulatory authority regulations relative to drug trials