Contract Clinical Research Associate Jobs

Required knowledge, skills, and abilities

Administering investigational medications or providing patient education regarding administration, as necessary

Ability to properly execute research responsibilities as delegated by the Principal Investigator

Adequate technological skills to adapt to new programs, systems, or devices

Ability and comfort in working with remote personnel

Knowledge of clinical documentation practices

Strong technological background and working knowledge of data management systems including the Google Suite

Manage the use and upkeep of data collection equipment and support the day-to-day operations of the Lab

Provide a world-class experience for our participants by running studies respectfully, efficiently, and maintaining a friendly and professional demeanor

Strong interpersonal communication skills with a savvy for working closely with study participants

Professional, timely, strong organization skills and attention to detail

This is a 9-month contract position with the possibility to extend based on performance and business need.*

Assist with essential documents collection, review and archiving (TMF management)

Provide project management support for PTX project team, including vendor oversight

Conduct Site Initiation, Routine, and Close-out monitoring site visits, either on-site or remotely, prepare visit correspondence and records including trip reports

Oversee the conduct of assigned study sites, including ensuring compliance with SOPs, federal and local regulations, and ICH and GCP guidelines

Assist in the review and /or development of clinical trial documents such as study plans and training materials

Participate in and assist with facilitation of project team meetings

Be constantly curious. Ask questions. Find answers. Always look for opportunities to learn and experience something new.

Create community through experience. Treat every moment as an opportunity to create meaningful experiences to share. Shared moments build community.

Strengthen our measurement capabilities on our streaming networks to drive increased revenue through audience intelligence, campaign efficiencies, and performance

Extensive experience in data analysis and storytelling, going beyond the ''what'' to tell the ''why'' within research results

Robust knowledge of the digital/social / video ecosystem, measurement capability landscape, and how it all works from a technical perspective

Excellent presentation skills; at times, join the sales team in meetings with clients

Experience maintaining a lab notebook and following written protocols with excellent problem-solving skills.

Learn about clinical bioanalytic regulation requirements.

BS/MS in with 1+ years experience in a research setting.

Must have experience with PCR

Must have knowledge of flow cytometry, MSD, and enzymatic assays

Experience with histology is a plus

· Prepares and attends assessment visits with less experienced CRAs, as required.

· Sound knowledge of medical terminology.

· Excellent communication in English in both written and verbal skills.

· Excellent interpersonal and organizational skills.

· Ability to manage more than 1 study simultaneously.

· Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.

Strong organizational, time management, and documentation skills

Manage inventory of required materials and maintain lab equipment to support DNA construction and preparation

Excellent communication and interpersonal skills

Experience with wet lab automation system such as Biomek, Echo, Qpix

Experience with high throughput DNA analysis on TapeStation, LabChip, Lunatic

Experience with bioinformatics and NGS

Other duties as assigned by management.

Bachelor's Degree in Business / Finance or industry related field

Works with Supplier Relationship Manager and Legal to establish Master Services Agreement (MSA) for as many suppliers as possible.

Works with Supplier Relationship Manager to incorporate Key Performance Indicators into contracts for applicable suppliers.

Evaluate changes in study protocols to determine the impact on clinical trial site budgets; develop, negotiate and finalize budget amendments.

Establish Purchase Orders (PO), review related Invoices, track spend against contracts / PO’s, and report spend as necessary.

Adhere to all laboratory safety requirements and procedures

Strong communication and collaboration skills

Strong organizational skills that enable a high level of productivity and timely completion of assignments

Excellent oral and written communication skills for effectively interfacing with all members of the company

Knowledge of nucleic acid chemistry and biology is a plus

Work both independently and as part of a collaborative team to adapt to changing priorities in a fast-paced environment

Required knowledge, skills, and abilities

Administering investigational medications or providing patient education regarding administration, as necessary

Ability to properly execute research responsibilities as delegated by the Principal Investigator

Adequate technological skills to adapt to new programs, systems, or devices

Ability and comfort in working with remote personnel

Knowledge of clinical documentation practices

Strong organization and time management skills with ability to multi-task while remaining detail-oriented in a highly time sensitive environment.

Outstanding verbal and written skills proven in either a legal, University or academic medical center setting are required.

Knowledge of contract law, legal terms and conditions, and FAR and OMB Circulars related to sponsored research is preferred.

Prepares, negotiates, executes and distributes outgoing contracts, subcontracts and other agreements. Enters agreement status data into tracking system. (essential)

Identifies and mitigates regulatory compliance, legal, intellectual property, and other risks. (essential)

Works with other Research & Academic Affairs divisions as a resource for input and information as needed. (essential)

Support the management of eTMF documentation issues throughout the lifecycle of a study

Proactive management of clinical documentation and trackers

Experience working with documents at study start-up, during study conduct and close-out will be required

Experience in handling TMF documents during a regulatory inspection will be a plus.

Proactive and smart organizational skills

Excellent documentation skills and detail-orientation

Ensure protocol and regulatory compliance, quality of data, and clinical site staff training, manage study sites

Knowledge of GCP and ICH guidelines required

The CRA should have the following Qualifications…

Bachelor’s degree in a relevant scientific discipline or equivalent

Job Title: Contract Clinical Research Associate

Salary: $70 USD - $85 USD Per Hour