Clinical Research Associate II/Sr. (1037)

FLSA Classification : Salary, Exempt
Schedule: Monday - Friday; 8:00 am - 5:00 pm; preferred Northeast region of USA
Department: Clinical Operations
Reports to: Associate Director, Clinical Operations
Supervisory responsibilities: No
Location: Remote or office based in Houston at 13203 Murphy Rd., Stafford, TX 77477
Position Summary/objective:
Responsible for the clinical monitoring activities for assigned clinical trial sites in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality and timely delivery.
Essential functions:

• Support clinical trial site feasibility.

• Conduct all aspects of clinical monitoring for clinical trials including site visits for qualification, initiation, routine monitoring and close-out.

• Conduct all aspects of site management as prescribed in the clinical trial specific functional plans.

• Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiate appropriate actions to achieve objectives.

• Support the maintenance of the Investigator Site Files and Trial Master Files

• Prepare accurate and timely monitoring visit reports.

Secondary functions:

• Maintain clinical trial tracker.

• Organize and present content at Investigator Meetings

• Participate in the development of Case Report Forms and clinical trial documents.

• Act as contact for clinical trial supplies and other suppliers (vendors)

• Prepare and review Standard Operations Procedures and Working Instructions as well as template documents.

Competencies:

• Excellent communication (written/verbal) skills.

• Positive attitude and willingness to learn and contribute in a team.

• Excellent organizational skills to work efficiently, good time management.

• Exceptional attention to detail

• Team player with excellent negotiation and conflict resolution skills

• Demonstrates ability to take initiative and work independently.

• Ability to prioritize and adapt quickly in a fast-paced and changing industry.

• Outside the box thinking and a high degree of flexibility in an environment which is marked by a constant striving for excellence

Work environment:
This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.
Physical demands:

• Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.

• Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.

• Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.

• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.

• Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).

• Pushing - Exerting force upon an object so that the object moves away from the object.

• Pulling - Exerting force upon an object so that the object moves toward the force.

• Sitting - remaining in a sitting position for at least 50% of the time.

• Standing/Walking - remain on one's feet in an upright position at a workstation.

• Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.

Travel required: Travel is an essential function of the job (>75%)
Required education and experience:

• Bachelor's degree preferably in life science or nursing, or you have a comparable education.

• 5-7 years of on-site monitoring experience in the pharmaceutical/ biotechnology industry.

• Understanding of medical oncology terminology and science.

• Excellent communication and interpersonal skills, with the ability to build strong relationships with trial site staff and internal team members.

• Strong organizational skills, with the ability to manage multiple projects and meet deadlines.

• n-depth knowledge of ICH-GCP, FDA, EMA and applicable local regulations and laws.

• Valid Driver's license

• Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS)

Preferred education and experience:

• Excellent English knowledge (written and spoken)

Work authorization/security clearance requirements:
Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.
Affirmative Action/EEO statement:
Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medicalconditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law."
Other duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.