AIM OF THE POSITION

The Clinical Research Associate monitors activities at clinical research study sites and ensures adherence to study protocols and SOPs.

POSITION WITHIN THE ORGANIZATION

1. Reports to Director of Clinical Research

2. Cooperates with all departments across the organization

3. Participates in:

- Department meetings

- Project meetings

- Working groups

- Project groups

ESSENTIAL DUTIES AND RESPONSIBILITIES

* Coordination and management of clinical trial sites including but not limited to supporting the study start-up process (assist in the collection of key regulatory documentation for submission to the IRB/EC, as well as assisting with budget and contract negotiations), routine site management, and site closure

* Conduct monitoring visits (Site Initiation Visit, Interim Monitoring Visit, Close-out Visit) either on-site or via remote review of data collected: if the protocol is adhered to, if the study is performed in compliance with GCP, checks if IRB approvals are still valid and in place.

* Review eCRF data for accuracy and completeness

* Review eCRF data for inconsistencies and issue queries to ensure database is clean and that reliable data has been collected

* Build, foster, and maintain good relations with investigators and site staff as well as collaborating with other cross functional groups at Agendia (such as Medical and Commercial as needed), and external vendors

* Ensure all site staff receives appropriate training and materials in order to conduct the study per protocol

* Ensure that the rights, well-being, and safety of human subjects are protected by verifying that informed consent procedures and protocol requirements are adhered to according to regulatory requirements.

* Maintain proper documentation of all relevant site correspondence and ensure relevant communications are filed in the Trial Master File (TMF).

* Conduct a TMF review, by site, as needed.

* Contact and engage sites, assists with logistics for study execution and enrollment

* Invoice creation and submission for payment to participating institutions

* Assist in the training and mentoring of Clinical Operations team.

* Performs other related duties as required or assigned.

KEY CONTACTS

Internal

* This position may interface with all departments within the company.

External:

* Will interface with outside institutions, vendors, and regulatory agencies.

EDUCATION AND EXPERIENCE REQUIREMENTS

EDUCATION

* Bachelor's degree required (preferably in a healthcare related field). Master's degree preferred.

EXPERIENCE

* 3+ years experience working in Oncology (as a monitor, coordinator, or nurse). Breast cancer experience preferred.

* 2+ years site monitoring experience

* In-depth experience with each stage of a clinical trial (i.e. study start-up through archive) and study site management

* In-depth experience with each type of site monitoring visit (pre-study, initiation, interim, close-out)

Certificates and License Requirements:

* Completion of ICH/GCP course

KNOWLEDGE, SKILLS AND ABILITIES (KSA'S)

Specific Knowledge Required: ICH/GCP

Knowledge: Comprehension of a body of information acquired by experience or study.

Skill: A present, observable competence to perform a learned activity.

Ability: Competence to perform an observable behavior.

* Thorough knowledge of FDA GCP-ICH Guidelines and local regulatory requirements

* Customer service orientation

* Sound knowledge of medical terminology and clinical monitoring process

* In depth therapeutic and protocol knowledge as provided in company training

* Excellent verbal and written communications skills

* Excellent interpersonal and organizational skills and attention to detail

* In Depth knowledge of guidelines and regulations for informed consent

* Knowledge of documenting in an Electronic Medical Record (EMR).

* Knowledge of clinical trials records, procedures, and computerized data processing systems.

* Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.

* Ability to use discretion and maintain privacy, confidentiality or anonymity.

* Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.

* Ability to convey and/or receive written/verbal information to/from various audiences in different formats.

* Must present a professional demeanor and interactions with the research community including research participants and/or family members, leadership, investigators, research nurses, coordinators, research pharmacy, sponsored research staff, and other ancillary service departments.

* Computer literacy, proficiency in MS Office

Desired Skills:

* Strong Leadership Skills

* CCRA Certification - Association of Clinical Research Professionals

* PRIVACY NOTICE: To review the California privacy notice, click here: https://agendia.com/privacy-policy/

WORKING ENVIRONMENT

Establishes ADA (Americans with Disabilities Act) requirements

ENVIRONMENT/SAFETY/WORK CONDITIONS

Working conditions (inside or outside the office).

• Office Environment
• Fully remote position

TRAVEL

Travel up to 50%

OTHER DUTIES

Other duties as required.