Description: PRINCIPAL TASKS AND DUTIES:

 Site Identification: Support the local study team in performing country and/or site feasibility.

 Trial documentation: Support the preparation of study files and of any other document required pretrial.

Study Start Up Activities / Site start-up

 Help LTM/SM/CTA in ensuring that the current versions of the required trial documents, trial-related

materials and supplies are provided to the investigational site within required timeframes, as

applicable.

 Support the LTM/SM/CTA in collecting/preparing documents required for study start-up and ECs and/or

Health Authorities Submissions.

 Help the SM in obtaining site related trial documents.

 Support the LTM/SM/CTA in collecting and processing as appropriate the IFDF and related documents

throughout the trial.

 May assist the LTM/SM/CTA in conducting local investigator meeting or with making arrangements for

the investigators participating in an international meeting, as applicable.

 Help in the distribution, collection, reviewing, and tracking of regulatory documents, agreements and

training documentation.

Study Execution Activities

 Support LTM/SM/CTA in drug distribution process, where applicable.

 Support LTM/SM/CTA in ensuring that during the trial all relevant trial related documentation is

provided to investigators and central / local IEC (if applicable) within the timelines.

 Support the LTM/SM/CTA in maintaining the study files.

 Provide administrative and logistic support to LTM/SM/CTA in tracking of progress of the trial,

management of study data, organizing meetings, mailing and correspondence, materials and other

relevant tasks as appropriate, where applicable.

Study Close Out Activities

 Site closure: Provide administrative and logistic support to the LTM/SM/CTA in activities related to

study/site closure, as appropriate, and follow up of all items identified, including support in collecting,

processing and archiving of study related documents as appropriate.

General Activities

 Base all actions on Credo. Protect the rights of others, protect privacy and company assets.

 Work in line with the HCC, company policies and procedures, including SOPs, having the ethical aspect

in mind.

 Comply with ICH-GCP and all applicable local laws and regulations.

 Maintain communication with relevant parties within and outside the company.

 Actively follow trainings and complies with relevant training requirements to ensure adequate

qualification.

 Regularly update information in applicable systems and templates (including contact information in

relevant systems to ensure appropriate safety updates distribution).

 Use appropriate systems to ensure file completeness at designated study milestones.

 Contribute to maintain quality standards and timelines that are consistent with business needs.

 Ensure inspection readiness at all times.

 Report every J&J product related complaint received to the company, according to policies.

 May contribute to process improvement.

TV-eFRM-12840 – ISR - Intern Tasks Description, version 4.0

REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides.

Primary Reporting Structure: Reports to Intern Manager.

WORKING RELATIONSHIPS/INTERFACES: Describe the primary working relationships (internal & external) and primary

interfaces along with the frequency and purpose/nature.

Primary interfaces: CRM, LTM, CTA, and SM(s) for assigned clinical studies.

Other Internal interfaces: GCO Country Head, Clinical Trial Manager (CTM), Local Compliance Manager/Specialist,

Contracts Centralized Services (CCS).

Relationships with the following departments: Pharmacovigilance (SAEs), IT (technical support), Local Medication

Coordinator and Human Resources.

Qualifications:

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
• Skills set corresponding with 0-2 years relevant clinical trial experience is preferred; however, other relevant
• Proficient in English language.
• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
• Strong interpersonal and negotiating skills preferred.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
• Ability to perform activities in a timely and accurate manner.