Senior Clinical Research Associate

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role
The Senior Clinical Research Associate (Senior CRA) reports directly to a member of the Clinical Monitoring Management team, as defined in the current organizational chart. The SCRA performs monitoring activities for clinical research projects according to the Clinical Monitoring Plans (CMPs) to assess the studies progress at assigned investigator sites (either on-site or remotely) and to ensure projects are conducted, recorded, and reported in accordance with the Protocol, Altasciences and Sponsor (when applicable) standard operating procedures (SOPs), ICH-GCP and applicable local and federal regulatory requirements. The Senior CRA coordinates the monitoring activities at the site level and is the main contact person for any questions (internal/external) related to the monitoring activities.

Preferred candidate will reside in or near Dallas, TX or Atlanta, GA due to these locations being the travel hub for this role.

What You’ll Do Here

• Create Clinical Monitoring Plans (CMPs) and prepare required Site Initiation Visits documents (e.g., Power Point presentations).

• Perform site qualification, initiation, interim, and close-out visits (either on-site or remotely) accordingly to the CMPs.

• Document activities via confirmation letters, visit reports, follow-up letters, and any other study-specific documents as per the CMP

• Assess the sites processes.

• Perform Source Documentation Verification (SDV) of source documents.

• Perform dosing observations and/or assist to Investigational Products (IPs) dispensation.

• Verify clinical data entered in the Case Report Forms (CRFs) and/or electronic CRFs (eCRFs).

• Apply query resolution techniques and provide guidance to site staff as necessary, driving queries resolution within agreed timelines.

• Review the Investigator Site Files (ISFs).

• Review IPs inventory, reconciliation, and storage conditions.

• Review and track Serious Adverse Events (SAEs).

• Review study Protocols, Informed Consent Forms (ICFs) and any other study-specific documents.

• Responsible for leading complex projects and involving multiple resources.

• Interprets data to recommend plans and tactics.

• Provides advice, guidance and answers to management on sensitive strategic matters pertaining to the entire organization.

• Train study site personnel on the Protocol, study-specific documents, and applicable regulatory requirements in collaboration with assigned project team members.

• Ensure monitoring SOPs and templates are up-to-date and update them as required.

• At the site level: Assist with planning/scheduling, assigning, tracking, and overseeing the monitoring activities, including the internal reports revision.

• Assists in managing and helping create clinical trial tracking metrics and reporting.

• Mentoring, training for Clinical Research Associates.

• Review and approve monitoring documents.

What You’ll Need to Succeed

• Bachelor's or equivalent health related (e.g., Medical, Scientific, Nursing) degree preferred.

• Minimum of 5 years of clinically-related experience, of which a period of 2 years is preferable in clinical research monitoring or equivalent experience.

• Knowledge of clinical research industry, terminology and practices.

• Knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.

• Strong verbal and written communication skills.

• Familiarity with EDC systems; ability to learn required systems quickly and to train others, especially site staff.

• Ability to meet deadlines, multitasks, and prioritize based on study needs.

• Ability to make sound decisions based on available information.

• Ability to establish and main